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
Where you are taking over your role from someone else and you are offered a handover Make the most of any chance to connect with your predecessor—even a short telephone call can be invaluable. Even minimal contact can surface practical pointers and context you might otherwise miss. This Checklist is for new in-house lawyers joining an organisation to replace the organisation’s previous in-house lawyer. It highlights key areas to address during any handover, however brief, and should be read alongside Practice Note: Taking up a new role in-house—replacing a previous in-house lawyer. Use what you hear to shape your immediate focus, not to constrain your judgement. That said, the position is now yours and you need not feel compelled to continue exactly as before. There are always several ways to approach matters and you should leave your own imprint on the role. Build on what was...
This Checklist This Checklist outlines several principal steps that schemes must undertake with effect from 24 July 2014 to meet the requirements of section 29 of the Pensions Act 2011 (“section 29”). That provision revises the meaning of money purchase benefits in section 181 of the Pension Schemes Act 1993, with the effect that some categories of benefit cease to be money purchase. For further detail on the impact of the updated statutory definition of money purchase benefits on schemes, refer to Practice Note: Money purchase benefits—the transitional regulations [ Archived]......
Basic terms At the outset, assess whether overage suits the transaction. Your client might be better protected by agreeing a higher purchase price or by entering into a conditional contract instead. Overage provisions can be intricate and expensive to negotiate. If overage is to be applied, consider when the seller expects or hopes to receive a further payment and how the buyer could avoid activating the overage. Ensure the overage includes clear definitions of: the overage period (note that, from 6 April 2010, the rule against perpetuities does not apply to most commercial interests and, if no overage period is specified, there is a risk the arrangement could be perpetual) the property that will be subject to the overage any individual units to be sold or constructed, making clear whether parking spaces and other ancillary areas form part of a unit for the...
Basic terms At the outset, assess whether an overage arrangement is right for the deal. Your client might be better served by agreeing a higher purchase price or entering into a conditional contract instead. Overage provisions can be intricate and costly to negotiate. If overage will apply, check that the terms reflect the buyer’s intended use of the site. the overage period (note that, from 6 April 2010, the rule against perpetuities does not apply to most commercial interests and, if no period is specified, there is a risk the agreement could be perpetual) the property that will be subject to the overage any individual units to be sold or built, making clear whether parking spaces and other ancillary areas are included within a unit for the overage calculation Include a ‘good faith’ clause, as this may help in the event of a dispute......
Funder’s primary objective When a buyer takes property subject to overage and seeks finance secured on that asset, a funder will require assurance that the overage provisions do not obstruct or curtail enforcement of its security. The lender must be confident its charge constitutes sound security over the property. Property and associated rights Assess the character of the site to be charged. Where it forms part of a broader development, consider whether, on a power of sale being exercised, the property will depend on rights over adjoining land held (or to be acquired) by the buyer, such as: rights of way rights concerning service media rights of support If such rights are necessary, agree a form of deed of easement to be annexed to the charge, and allow the funder to require grant of that easement when needed. Also examine whether the seller’s chosen mechanism for securing the overage is...
When to seek settlement? This checklist flags common issues that can emerge when negotiating and drafting a settlement agreement. For step-by-step guidance on negotiating and preparing a settlement agreement, consult the following Practice Notes: How to agree and draft a settlement agreement (non-employment claims) Settling disputes—how to document a settlement Settling disputes—drafting the settlement agreement Keep settlement in mind at every stage of a dispute, including pre-action. Consider the full range of resolution routes, such as direct negotiation between the parties or their legal advisers, assessing whether a Part 36 offer is suitable, or engaging in assisted alternative dispute resolution ( ADR), for example mediation. Following a rule change in October 2024, the court may now order parties to participate in ADR (see CPR 3.1(2)(o)). Review any contractual duties relating to settlement—such as a tiered dispute resolution clause—and ensure...
For more practical, step-by-step guidance on solar projects, including viewpoints from several jurisdictions, consult the textbook also: Solar Power: A Practical Handbook. Negotiating a rooftop lease for solar PV panels When arranging a rooftop lease for solar PV panels, the matters at stake will differ according to the interests of the party you represent. Those issues shift depending upon whether one acts for the landlord, the occupier, or the solar tenant. Here, 'landlord' describes the owner of the freehold or a long lease of the relevant building; 'occupier' means the party in occupation; and 'solar tenant' is the entity proposing to install and own the panels. The solar tenant may equally be the building’s occupier, or could be a dedicated solar developer. A growing number of landlords are fitting solar panels to their properties—either via the same corporate vehicle that holds the building, or through a...
This Checklist sets out the matters a buyer’s legal due diligence ought to cover to evaluate the potential effect of the UK’s National Security and Investment Act 2021 ( NSI Act) on the deal... Preliminary considerations The buyer’s legal due diligence should factor in the potential implications of the UK’s NSI Act on the transaction (see Practice Note: The National Security and Investment Act 2021). The principal NSI Act-related diligence points include: confirming whether any undertaking within the target’s group conducts activities that fall within sectors of the economy requiring mandatory notification under the NSI Act where the transaction does not meet the mandatory notification criteria, assessing whether there remains a meaningful risk of the transaction being called in for a national security review checking whether any member of the target’s group has been involved in a trigger event since 12...
Checklist This Checklist sets out key provisions commonly included in a mobile virtual network operator ( MVNO) agreement, under which a mobile network operator, as Supplier, provides wholesale access for resale to the MVNO’s own retail customers. It focuses on provisions specific to this type of contract. See also the Precedent: MVNO agreement. Definitions Agreement – the MVNO agreement between the MVNO and the Supplier for the provision of the Services End- User – a customer of the MVNO IPR – intellectual property rights MVNO – mobile virtual network operator, the customer in the Agreement Services – the wholesale network services provided to the MVNO by the Supplier Supplier – the mobile network operator supplying network services to the MVNO The third column can be used to capture observations or comments as the Checklist is...
This Checklist This checklist reflects the requirements for claims progressing on the multi-track under CPR 29 and CPR PD 29, which govern multi-track case management. It should be read alongside Practice Notes: Multi-track—case management and Multi-track—case management conference ( CMC), which provide general guidance on case management and on CMCs in the multi-track. This Checklist offers a high-level outline of key case management points to consider and deal with at an early stage of the proceedings and before any CMC takes place. It is not exhaustive and you will need to examine each point in greater depth where it is pertinent to the facts of the particular claim. The court’s case management of a claim will also vary according to the forum in which it is brought, and you must take into account the court-specific approach, including any guidance set out in that court’s guide. For...
ARCHIVED: This Practice Note is archived and is no longer maintained. On 31 March 2011, the European Commission ( Commission) put forward, via the co-decision process, a proposal to adopt a directive on credit agreements for consumers connected to residential immovable property. Subsequently, on 4 February 2014, the European Parliament and the Council of the EU formally adopted the Mortgage Credit Directive ( Directive 2014/17/ EU) ( MCD). Its publication in the Official Journal of the EU followed on 28 February 2014. The MCD covers first- and second-charge mortgages as well as consumer buy-to-let activity on the same basis. It sets out assumptions used to calculate the annual percentage rate of charge ( APRC). A tool built on these assumptions is available to assist users (including regulators, consumers, and creditors) in working out the APRC for a particular credit. Per the...
ARCHIVED: This Practice Note is archived and is no longer maintained. After reviewing shadow banking and investment funds, the European Commission highlighted several issues concerning money market funds ( MMFs). In response, it issued the original proposal for a Regulation on Money Market Funds ( MMF Regulation) in September 2013, reflecting recommendations from the International Organisation of Securities Commissions ( IOSCO) and the Financial Stability Board ( FSB). On 29 April 2015, the European Parliament voted on a package of amendments to the draft MMF Regulation. The final text was published in the Official Journal of the EU on 30 June 2017 and took effect on 21 July 2017. The MMF Regulation seeks to strengthen investor protection and to reduce the risks that MMFs may pose to the integrity and stability of financial markets......
This Checklist directs you to relevant Precedents you can adopt or adapt to meet the obligations of the Money Laundering, Terrorist Financing and Transfer of Funds ( Information on the Payer) Regulations 2017 ( MLR 2017), SI 2017/692, as amended, together with associated recommendations. It consolidates obligations in the MLR 2017, as amended, and also those found in the: National money laundering and terrorist financing risk assessment Legal Sector Affinity Group ( LSAG) Anti- Money Laundering ( AML) Guidance for the Legal Sector SRA sectoral money laundering and terrorist financing risk assessment various SRA and Law Society publications The Checklist highlights applicable Precedents you may use or modify to satisfy these obligations and recommendations in your practice where appropriate. A section is provided for you to record whether you have fulfilled each requirement and to add comments or note action...
This Checklist directs you to relevant Precedents to use or tailor so you meet the Money Laundering, Terrorist Financing and Transfer of Funds ( Information on the Payer) Regulations 2017 ( MLR 2017), SI 2017/692, as amended, and related recommendations. It includes a section to record completion of each task and space to add remarks or identify action points. Confirm whether the MLR 2017 impose extra or different obligations for your sector and whether your regulatory body sets any further, sector-specific requirements. Nominated officer For additional guidance, see Practice Note: Money Laundering Regulations 2017—nominated officer. Requirement | Compulsory or recommended? | Comments (if any) ☐ Determine: are you required to appoint a nominated officer? if yes, who will be your nominated officer? if no, will you...
This paper mirrors Legal Sector Affinity Group ( LSAG) AML guidance. Requirement Mandatory or advised? Notes (if any) ☐ Create a documented process regarding the origin of funds and the origin of wealth Recommended See Precedent: AML, CTF and counter-proliferation financing policy—law firms......
This record keeping checklist consolidates obligations found in the Money Laundering, Terrorist Financing and Transfer of Funds ( Information on the Payer) Regulations 2017 ( MLR 2017), SI 2017/692, as amended. It further sets out suggested actions and practical steps. The Checklist directs you towards relevant Precedents that you may adopt, adapt or tailor to meet these requirements and recommendations. For extra guidance, see Practice Note: Money Laundering Regulations 2017—record keeping or, for law firms, Money Laundering Regulations 2017—record keeping (law firms). The manner, medium or physical or digital location in which records are retained is immaterial, provided you can promptly retrieve the necessary information and evidence, especially if you are asked to supply customer/client due diligence ( CDD) documentation to a party that relies on you, or to investigators or other enforcement officers. Record type For how long? Compulsory or...
STOP PRESS: On 24 March 2025, the government released a comprehensively revised and updated version of its statutory guidance on the transparency in supply chains provisions in section 54 of the Modern Slavery Act 2015. This document is being reviewed in light of the new guidance. Section 54 of the Modern Slavery Act 2015 ( MSA 2015) requires any commercial organisation operating in the UK with an annual turnover over £36m to publish a yearly transparency statement explaining the actions taken during the financial year to prevent slavery and human trafficking within its supply chains and across its business. The statement may cover: Organisational structure Policies Due diligence Risk assessment and management Training Effectiveness in keeping the supply chain free from modern slavery and human trafficking Our Flowchart: Does section 54 of the Modern Slavery Act 2015 apply to my...
This Checklist sets out the points to address when preparing a mobile app end-user licence agreement ( EULA) for distribution via an app store. For template EULAs, see Precedents: Mobile app end-user licence agreement ( EULA)—generic; Mobile app end-user licence agreement ( EULA)—for Apple App Store; Mobile app end-user licence agreement ( EULA)—for Google Play. The third column can be used to capture observations or comments as you work through the Checklist... Checklist ☐ Take instructions Further information: Take instructions to understand the app’s features and functionality that may influence the EULA. See below for specific requirements for features such as augmented reality. ☐ Identify the relevant app store’s requirements ☐ Apple App Store: ensure the EULA includes Apple’s minimum terms Further information: Apple offers a default EULA, but allows app...
This checklist identifies those jurisdictions where merger control notification thresholds can arise from (1) the domestic activity of a single party, and (2) the domestic activity of only the purchaser alone. For further information on notification thresholds, please see MJ merger grid—jurisdiction. Single trigger jurisdictions–any party Jurisdictions in which merger control notification thresholds may potentially be reached via the local activity of any one party alone include: Albania Algeria Angola Argentina (note—various exemptions apply, including one tied to the size of the transaction value.)......
Non-controlling minority shareholdings This Checklist identifies the jurisdictions worldwide where acquisitions of non‑controlling minority shareholdings must be notified, provided the other jurisdictional thresholds are satisfied. In this context, ‘non‑controlling minority shareholdings’ means any degree of influence falling short of what the EU Merger Regulation terms ‘decisive influence’—namely, the capacity to exercise a significant level of control over an undertaking’s strategic commercial behaviour. That influence can be exercised through a variety of routes, including share ownership, voting rights (in particular, veto rights), or contractual arrangements, and does not necessarily involve holding a majority shareholding......
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 ]...