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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 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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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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CHECKLISTS

The documents set out below give a snapshot of the principal transactional papers commonly used to document a high yield bond issuance. For each, the summary outlines its function and identifies the relevant parties who would ordinarily sign it. Further documents might be necessary to address features of a particular deal (for example, escrow mechanics) or to capture tailored arrangements specific to that transaction... Document Description 144A Global Note A single note executed by the issuer evidencing the full principal amount for the Rule 144A tranche. Section 5 of the US Securities Act of 1933 requires every offer and sale of securities in the United States to be registered with the Securities and Exchange Commission ( SEC) unless an exemption applies. Rule 144A provides a safe harbour from the Section 5 registration obligation, thereby permitting the initial purchasers of the bonds (see Purchase Agreement below) to...

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CHECKLISTS

Time line for a standalone issue of bearer bonds, with listing taking place on a regulated market upon admission...

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CHECKLISTS

This Checklist highlights the matters a franchisor should weigh up before launching a franchise in a foreign market. Advances in technology have significantly accelerated the development of a global economy, helping to facilitate cross-border trade and expansion. Consequently, there are growing opportunities for companies to trade beyond their home markets and capitalise on developing territories. Nevertheless, when a franchisor prepares to operate abroad, numerous and varied issues emerge, some of which are set out below. PESTLE analysis A franchisor may choose to undertake a political, economic, environmental, sociological, technological, legal and environmental factors ( PESTLE) review for the target jurisdiction as part of its initial planning. Insights gathered from that assessment can inform and guide strategic decision-making when evaluating cross-border franchising. Set out below are legal and non-legal matters that may arise in an international franchising...

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CHECKLISTS

The employee (and their adviser) should consider the following issues: Preparatory steps Gather: a copy of the employee’s most recent employment contract and any other documents setting out contractual terms (these might be found in a staff handbook) a P45 or the latest payslip details of the contractual benefits the employee receives relevant information about the employee’s pension benefits relevant details of any shares or share options held by the employee. Review the Articles of Association, any applicable shareholder agreement and share scheme documents. See also Shares and share options below copies of pertinent open correspondence and without prejudice communications between employer and employee ...

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CHECKLISTS

The employer and its advisers ought to reflect on the following matters: Preparatory steps From the employer, gather: a copy of the departing employee’s latest employment contract and any other documents setting out contractual terms (note: these might sit within a staff handbook) particulars of the employee’s contractual benefits pertinent details about the employee’s pension entitlements information on any shares/share options held by the employee; review the Articles of Association, any relevant shareholder agreement, and share scheme documentation. See also Shares and share options below Status of negotiations Will discussions occur directly between the parties, or via their respective legal advisers? How robust is the employer’s bargaining position? How credible are the...

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CHECKLISTS

For the approach applying from 1 October 2020, refer to: Issues to consider when completing costs budget—checklist. This Checklist addresses the position up to and including 30 September 2020. It explores the range of points that can surface when preparing a costs budget, otherwise referred to as Precedent H. It is presented as a series of questions and answers. Bear in mind that case costs differ according to each matter’s particular facts; accordingly, the topics outlined below are generic in nature. A link is also included to a fully interactive version of Precedent H. General comments Question Response Question: Must I complete a costs budget? Response: A costs budget must be prepared, filed with the court and served on the other parties to the proceedings unless the proceedings are excluded from the costs budgeting rules. Where excluded, no budget is required unless the court orders...

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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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