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LIFE SCIENCES

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

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CONSTRUCTION

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

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PROPERTY

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

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CHECKLISTS

This Checklist This Checklist identifies the principal terms to weigh up within a consultancy agreement. It draws attention to points affecting the customer, matters impacting the consultant, and considerations shared by both sides for incorporation into a consultancy agreement. The Checklist supports both consultant and customer as they assess and bargain over a consultancy agreement, effectively guiding review and negotiation throughout the process. See also: Taking instructions for a consultancy agreement—checklist......

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CHECKLISTS

This Checklist flags the usual key policies that an organisation should think about putting in place, and it points to Lexis Nexis® Precedents you may use or tailor as appropriate. Having robust policies and procedures established will assist an organisation to control risk and also evidence compliance wherever a written policy is a regulatory necessity. Note: this Checklist is not meant to be a complete catalogue of every policy an organisation ought to hold. Extra or alternative policies might be needed from time to time to fit your organisation or to satisfy any industry or sector-specific regulatory obligations. General human resources policies Policy — Aim of this policy — Lexis Nexis® Precedents you could use or adapt (available subject to subscription) Adoption leave policy — To outline an organisation’s approach to adoption leave and pay. Policy—adoption leave Carer’s leave policy — To state an...

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CHECKLISTS

Prepared in conjunction with 4 Pump Court, this Checklist serves as a springboard for a responding party drafting its Response in an adjudication. The matters to be tackled will vary with the dispute’s specific facts and circumstances, but the list sets out the principal points to weigh and directs you to guidance on each. See also Practice Note: Adjudication—the Response for help on the Response, including practical drafting tips, and Checklist: Key issues to consider on receipt of a Notice of Adjudication. Initial considerations Identify any requirements for the Response, including its service deadline and any stipulations as to form and/or content, for example: are there express provisions about the Response in the parties’ contract or the applicable adjudication rules? has the adjudicator issued directions for the Response (which may override contractual requirements)? Timing: there is no statutory time limit for...

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CHECKLISTS

Created in collaboration with 4 Pump Court. This Checklist highlights several principal matters a responding party ought to review on receiving a Notice of Adjudication. That review includes assessing whether grounds exist for a jurisdictional objection—if they do, the responding party must take particular actions so as not to forfeit its ability to advance the objection (either within the adjudication or later at enforcement). Further direction on jurisdiction can be found in Practice Notes: Grounds for a jurisdictional challenge in an adjudication and Making a jurisdictional challenge. Are there possible grounds to dispute the adjudicator’s jurisdiction? Initial points to consider include: the contract: is there a contract between the parties to the adjudication and has it been properly identified in the Notice of Adjudication? See Practice Note: The Notice of...

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CHECKLISTS

Prepared in partnership with 4 Pump Court. This checklist sets out the principal issues you need to consider upon receiving an adjudicator’s decision. The main issues At the very outset, there are three principal points that warrant attention: are there any mistakes in the decision that could be corrected under the slip rule? is the outcome capable of enforcement? is the outcome acceptable, or is a final determination required and, if so, can this be pursued through Part 8 proceedings? Enforceability Issues It is important to assess whether the decision is enforceable, or whether it may properly be challenged. Please note that the grounds for challenging an adjudicator’s decision are limited—see Practice Note: Resisting enforcement of an adjudication decision......

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CHECKLISTS

What are the key issues property lawyers should consider in real estate finance transactions when acting for a funder? Understanding the deal’s nature and objective is crucial—above all, establish whether it is an investment facility or a development facility, as this will govern the principal matters to address. See further Practice Notes: Introduction to real estate finance—the lending structure, Real estate finance—development facilities—key features and Real estate finance—investment facilities—key features. Due diligence and investigating title At times a funder may instruct its solicitor to carry out first-hand due diligence; in that case, see Practice Notes: Property due diligence in corporate transactions, Reporting to a lender in an investment real estate finance transaction and Real estate in corporate transactions—overview. More typically, the funder will rely on a London Law Society ( CLLS) certificate of title ( Certificate) prepared by the borrower’s solicitor and reviewed by the...

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CHECKLISTS

This Checklist This Checklist examines the intellectual property elements of vertical agreements and outlines the principal competition law issues. It addresses: the parties and configuration of vertical arrangements identification of the IP licence scope limits on use of the IP IP ownership third-party IP protection of the licensor’s IP warranties and indemnities On 10 May 2022, the European Commission adopted the EU Vertical Restraints Block Exemption, Regulation ( EU) 2022/720 ( EU VBER), along with the Vertical Guidelines. The EU VBER came into force on 1 June 2022 and will expire on 31 May 2034. See Practice Note: The Vertical Block Exemption Regulation 2022/720. On 9 May 2022, the UK government laid before Parliament the Competition Act 1998 ( Vertical Agreements Block Exemption) Order 2022 ( UK VABEO), SI 2022/516. The UK VABEO replaced the UK Retained VBER on 1 June...

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CHECKLISTS

This Checklist outlines the principal documents and information funders need to tackle the matters identified in What funders look for—checklist. Issue Documents Comments Documents available Liability As an initial step, the funder will seek the essential documents so it can evaluate the claim’s prospects from a liability angle. The funder is likewise prone to ask for copies of any counsel’s opinions, or those from the instructed solicitors, regarding the strength of the case. Certain funders will invariably demand that such an opinion has been prepared prior to moving the claim ahead before further step is taken......

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CHECKLISTS

ARCHIVED : This Practice Note is archived and is no longer maintained. The LEI is a 20-character, alphanumeric identifier created by the International Organisation for Standardisation ( ISO). Under Article 5 of Commission Delegated Regulation ( EU) 2017/590, a Level 2 instrument under Mi FID II, from 3 January 2018 firms carrying out transactions must hold a valid LEI at all times and ensure their LEI is used to identify them in transaction reports. For detail on this obligation, refer to Practice Note: EU MIFID II & MIFIR— Transaction Reporting. The Global LEI System High Level Principles and the FSB’s recommendations were issued in 2012 and received G20 endorsement......

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CHECKLISTS

This Checklist This Checklist presents a comparison table outlining the key consumer information obligations set out in: the Consumer Contracts ( Information, Cancellation and Additional Charges) Regulations 2013, SI 2013/3134 ( CCR 2013) the Provision of Services Regulations 2009, SI 2009/2999 ( PSR 2009) the Electronic Commerce ( EC Directive) Regulations 2002, SI 2002/2013 ( E- Commerce Regulations 2002) As shown by the table below, numerous information duties in the PSR 2009 and the E- Commerce Regulations 2002 correspond with those in the CCR 2013. That said, both the PSR 2009 and the E- Commerce Regulations 2002 also set out further specific information requirements that traders must take into account where those rules apply, and this Checklist is designed to support traders in meeting their compliance obligations. The focus of this Checklist is the information requirements contained in the UK...

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CHECKLISTS

This checklist highlights the jurisdictions that have a transaction value threshold...

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CHECKLISTS

It is quite common for a claimant to ask that a judicial review claim is dealt with urgently. This checklist sets out the principal procedural steps and key factors for anyone drafting, checking or answering an application for urgent consideration in the Administrative Court. It should be read alongside Practice Note: Judicial review time limits—extensions and urgent cases. Request for urgent consideration— Form N463 If a claimant seeks urgent treatment of their judicial review application, the claim form ought to be filed together with an application for urgent consideration ( Form N463)......

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CHECKLISTS

This Checklist sets out the principal procedural steps and considerations for parties preparing or answering a request to extend time in judicial review claims before the Administrative Court. It should be read alongside Practice Note: Judicial review time limits—extensions and urgent cases. Time limits for bringing claims and the requirement to act 'promptly' Where proceedings are started in the High Court, the claim form must be lodged promptly and, in any case, no later than three months from the date the grounds first arose, subject to the shorter periods below: challenges to planning decisions must be issued within six weeks of the date the grounds to bring the claim first arose challenges to procurement decisions under the Public Contracts Regulations 2015 must be brought within 30 days of the date the...

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CHECKLISTS

Purpose of Checklist The aim of this Checklist is to set out the types of factors that should be kept in view, and about which direction will be required, when preparing a joint venture agreement (sometimes referred to as a shareholders’ agreement) together with the articles of association for a joint venture company ( JVC). It serves purely as guidance and does not claim to be comprehensive. This Checklist has been produced with English law requirements in mind and, while related issues will arise for an international joint venture agreement, one must acknowledge the limits of this Checklist where a foreign joint venture ( JV) vehicle is used. For a Checklist covering the initial matters to be considered, and on which instructions should be obtained, when contemplating entry into a JV structure with a JV vehicle that is a private company limited by shares, see...

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CHECKLISTS

This Checklist flags the typical matters encountered during the drafting of outsourcing contracts, and can be applied in conjunction with the following Precedents: Outsourcing agreement—long form Outsourcing agreement—short form For more detail on points covered here, consult these Practice Notes: Negotiation guide— IT contracts Outsourcing—key terms Key issues in IT outsourcing The evolution of IT outsourcing See also the IT contracts negotiation checklist. Use the third column to capture remarks or notes while progressing through the Checklist, during completion of the Checklist, noting observations and comments. Checklist Further information Notes (if any) Initial due diligence Confirm which due diligence has been undertaken or remains outstanding......

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CHECKLISTS

Introduction This checklist sits alongside the fuller Practice Note: Negotiation guide— IT contracts and serves as a quick-reference point, concentrating on the principal general matters that commonly surface in IT agreements. Its emphasis is on the key, general issues likely to arise in IT contracts. It deliberately excludes certain specialist topics covered in the Practice Note that arise only in particular IT arrangements or in higher-complexity engagements, such as: acceptance testing audit rights TUPE step-in rights benchmarking exit assistance For each issue, it sets out the customer’s and supplier’s optimal positions and then proposes a balanced middle ground, which is indicative rather than exhaustive. For a fuller discussion and explanation of each point, see Practice Note: Negotiation guide— IT contracts. To view balanced precedents that put much of what is discussed here, and in the negotiation guide, into practice, refer to: Precedents: Framework agreement for the provision of IT products and...

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CHECKLISTS

What is an offshore fund? This flowchart explains the process for assessing if a fund is treated as an offshore fund for UK tax purposes. For further detail on the elements comprising the definition of an offshore fund, see Practice Note: Tax and offshore funds—what is an offshore fund? What is an offshore fund?......

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CHECKLISTS

ARCHIVED: 11 pm ( GMT) on 31 December 2020 signalled the close of the Brexit transition/implementation phase that followed the UK’s departure from the EU. At that specific moment (known in UK law as ‘ IP completion day’), core transitional provisions ceased entirely. From IP completion day onwards, the UK is no longer able to participate actively in the European Arrest Warrant ( EAW), because EAWs are available solely to Member States......

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CHECKLISTS

Upon receipt of the arbitral award, parties, at the outset, should confirm it is ‘complete’, meaning it complies with formal requirements, and appreciate how vital these are for any challenges and/or appeals relating to the award, as well as its recognition and enforcement. The following Checklist, whilst not exhaustive, highlights several key considerations in particular: Is it in writing?......

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CHECKLISTS

Introduction Guidance on establishing a medium term note ( MTN) programme is set out in Practice Note: Setting up an MTN Programme—timeline of process. This Practice Note concentrates on the steps for an issuance of notes (a drawdown) carried out under an MTN programme (the programme) once that programme has been put in place. Type of drawdown A programme will ordinarily provide for two forms of drawdown: a drawdown agreed between the issuer and a dealer (a dealer drawdown); and a drawdown agreed between the issuer and a group, or syndicate, of dealers (a syndicated drawdown). In addition, the programme will usually permit further dealers to accede to the programme, either as permanent members of the dealer panel or for the purposes of a single drawdown. Notification to dealer(s) The issuer then notifies the dealer(s) of its intention to draw down under the programme—this can be done by means of a term sheet or by...

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Popular documents

When evaluating a general damages claim, the practitioner ought initially to refer to the Judicial College Guidelines (JCG)...

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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...

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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 ...

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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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