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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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This Checklist highlights the principal points to weigh up when entering into, drafting, or reviewing contractual joint venture arrangements. It addresses the legal, regulatory and practical aspects surrounding such arrangements. For background, see Practice Notes: Contractual joint ventures; Drafting a contractual joint venture agreement; and Drafting for particular types of contractual joint venture. Preliminary issues for consideration What is the current position of the parties’ discussions? See Practice Note: Pre-contractual representations and statements. Is a confidentiality undertaking needed from one, some or all parties or their affiliates? See Practice Note: Practical steps to protect or obtain access to confidential information and Precedents: Confidentiality agreement—contractual joint venture; Confidentiality agreement—one-way—pro-discloser; Confidentiality agreement—one-way—pro-recipient; and Confidentiality agreement—mutual. Do the parties intend to reserve a period of exclusive negotiation? See Practice Note: Exclusivity in contract negotiations. Identify any potential roadblocks to the deal (for...

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CHECKLISTS

STOP PRESS: The Economic Crime and Corporate Transparency Act 2023 ( ECCTA 2023) obtained Royal Assent on 26 October 2023. Part 1 of ECCTA 2023 introduces a substantial suite of measures that strengthen the role of Companies House and promote greater transparency across UK corporate entities. The Act will be brought into effect in phases over an extended timeframe. Numerous provisions will depend on detailed secondary legislation and accompanying guidance, alongside the development and rollout of new technical systems, processes and tools to implement the reforms. For further information, see Practice Notes: The Economic Crime and Corporate Transparency Act 2023—what Banking & Finance lawyers need to know, The Economic Crime and Corporate Transparency Act 2023—tracker, and Corporate transparency reform—changes to company registers. What are a company's constitutional documents?......

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CHECKLISTS

STOP PRESS: The Economic Crime and Corporate Transparency Act 2023 ( ECCTA 2023) obtained Royal Assent on 26 October 2023. Part 1 of ECCTA 2023 sets out a substantial suite of measures that strengthen the role of Companies House and improve the transparency of UK corporate entities. The ECCTA 2023 will take effect gradually. Many aspects of the Act depend on detailed secondary legislation and guidance, as well as the creation of new technical processes and tools to deliver the reforms. For more, see Practice Notes: The Economic Crime and Corporate Transparency Act 2023—what Banking & Finance lawyers need to know, The Economic Crime and Corporate Transparency Act 2023—tracker, and Corporate transparency reform—changes to company registers. Board minutes As part of pre-completion steps and fulfilling conditions precedent, lawyers acting for a lender in a standard finance transaction must review the board minutes of the...

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Where a dispute arises, or is taken to have arisen, between a building owner and an adjoining owner concerning any matter associated with or connected to works falling under the Party Wall etc Act 1996 ( PWA 1996), one of two approaches applies: both parties jointly agree to appoint a single independent surveyor together, or each side appoints its own surveyor to produce a party wall award. If two surveyors are chosen, they must then select a third to determine any dispute between them. Any two of these appointed surveyors, or the third acting alone, may make the award. See the Practice Note: Party Wall works—notices, disputes and awards. What is a party wall award?......

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Who was the report commissioned for? Your client may have no entitlement to rely on a report that was not commissioned for them. If it was prepared for a different party, review the report’s terms and conditions, or the consultant’s appointment, to identify any express provision: authorising third parties to rely on the report, or mandating a collateral warranty or reliance letter to be issued in a pre-agreed form Where neither an express term nor a pre-agreed collateral warranty exists, consider seeking: a bespoke collateral warranty extending reliance to your client an assignment transferring the report to your client a reliance letter addressed to your client the report to be readdressed to your client, on clear terms and conditions to rely on the Contracts ( Rights of Third Parties) Act 1999, unless its operation is excluded in the terms and conditions It is also essential to confirm for whom the report was...

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Withholding tax is a key concern relating to loans. The objective is to ensure no withholding tax arises on interest, thereby avoiding the administrative burden and cost linked to withholding tax. For further detail in this area, see Practice Note: Tax considerations on a loan agreement—the tax gross up clause—a borrower problem. Loan documentation is typically prepared on terms favourable to lenders. That tendency is especially marked for syndicated loan facilities. Such contracts are generally structured for straightforward transfer between lenders and commonly follow, or are derived from, one of the model loan facility agreements of the Loan Market Association ( LMA). For an explanation of the rationale for gross-up clauses in loan agreements, see Practice Note: Tax considerations on a loan agreement—the tax gross up clause— Why have a tax gross-up?......

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This checklist outlines the principal points to assess when examining a collateral warranty on behalf of a funder. In this context, 'funder' denotes any lender or party that is providing finance in connection with a project. Finance documents Always ensure the warranty is checked thoroughly against any express requirements contained in the finance documents relating to collateral warranties, as such provisions may specifically prohibit the inclusion of particular clauses, eg caps on liability, and may equally prescribe minimum levels of insurance cover to be maintained by the warrantors. See: Facility agreements—construction provisions for further detail on the matters contained in finance agreements. Parties At the beginning, the funder ought to perform due diligence on the party giving the warranty......

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Checklist Use this Checklist when assessing a confidentiality agreement (also called a non-disclosure agreement or NDA) where you are the party receiving confidential information under that arrangement. Before you begin your review, consider: what information the business needs to obtain and for what reason; whether the business will also be sharing information with the other side; what information is being received and who should be able to access and use it. For further information, see Precedent: Confidentiality agreement—one-way—pro-recipient. The third column can be used to capture observations or comments as you work through the Checklist. Further information Notes (if any) ☐ Confirm the parties to the agreement. Reflect on which individuals and/or entities should be party to the agreement. □ Confirm how confidential information will be defined. Consider: whether a general...

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CHECKLISTS

This checklist outlines the regulatory obligations for financial services firms in relation to reverse stress testing. The requirements are located in chapter 7.5 of the Prudential sourcebook for Mi FID Investment Firms ( MIFIDPRU 7.5) within the Financial Conduct Authority ( FCA) Handbook (where reverse stress testing constitutes part of the internal capital adequacy and risk assessment ( ICARA) process) and in the Internal Capital Adequacy Assessment Part of the Prudential Regulation Authority ( PRA) Rulebook... What is reverse stress testing? Mi FIDPRU and the Internal Capital Adequacy Assessment Part provide comparable, though not matching, definitions of reverse stress testing......

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CHECKLISTS

Identity of retiring general partner Please confirm the retiring general partner’s name and address. Limited partnership agreement and other documentation In what manner does the limited partnership agreement set out the process for a general partner’s retirement, resignation and/or removal? Does the partnership terminate upon a general partner’s resignation or removal? If it continues, what proportion of limited partners must approve the appointment of a replacement or new general partner? Do the defined terms in the partnership agreement align with those used in the proposed retirement deed? Which post-retirement restrictions are currently in place and apply to the departing general partner? Are those restrictions reasonable in scope, duration and effect? Should any additional restrictions now be included? Will the retiring general partner be obliged to provide assistance to the new general partner (if any)...

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This checklist outlines the principal points to review and address when a member leaves a limited liability partnership ( LLP). It covers the associated legal, regulatory and practical matters that arise. Identity of retiring member Confirm the retiring member’s full name and current correspondence address? LLP agreement and other documentation What specific provisions in the LLP agreement govern a member’s retirement process? Which post-retirement restrictions currently bind the departing member in practice? Are those restraints proportionate and appropriate? Do they require any further additions or revisions? Must the former member provide assistance to the LLP after departure, if any? Are the current confidentiality duties on the retiring member sufficient and adequate? What releases from agreements or covenants (e.g. finance documents) does the retiring member need? Retirement details What is the member’s final date of service? Are...

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Identity of retiring partner What are the retiring partner’s full name and address? Business details Will the partnership’s business continue unchanged once the partner retires? Is a change to the partnership’s name planned after the partner’s retirement? Will the location or premises of the business alter? If the partnership is VAT-registered, who will notify HMRC of a change in partners for VAT purposes? If the partnership operates PAYE and pays employer’s NICs, who will advise HMRC of partner changes for these obligations? Will any incoming partner need to register for employee’s NICs? Partnership agreement and other documentation What does the partnership agreement stipulate regarding a partner’s retirement? Are the defined terms in the partnership agreement aligned with those in the proposed deed of retirement? What post-retirement restrictions apply to the departing partner? Are those...

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CHECKLISTS

ARCHIVED: This Checklist sets out information on retirement options for DC members prior to 6 April 2015. It is no longer maintained and is provided for background purposes only. For more information on retirement options for DC members, see Practice Note: Retirement options— DC members. Pre-6 April 2015 pension payment options Until 5 April 2015, a DC member’s pension pot could be applied to deliver one of the following pension payments: scheme pension — a ‘scheme pension’ is either a pension paid straight from the scheme’s own funds by the scheme administrator, or a pension arranged with an insurance company selected by the scheme administrator. DC occupational pension schemes and personal pension schemes did not usually make a scheme pension available......

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This Checklist This Checklist highlights key matters to weigh up when preparing and finalising a retention bond for a construction scheme. For additional guidance on retention bonds, see Practice Note: Retention bonds. Parties A party whose registered office is outside England and Wales may need to nominate an address for service within England and Wales. Consider carefully before accepting a surety located beyond the UK and, where relevant, confirm the surety is properly authorised to issue bonds in the UK. Always include company registration numbers to enable future identification of the companies. ......

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What are the initial considerations when served with a statutory demand? This Checklist highlights the principal points for an individual or company that has been served with a statutory demand (the debtor) by a party alleging a sum is due (the creditor). It offers a concise, dispute resolution perspective on the core issues. For comprehensive guidance and case law on statutory demands, see: Statutory demands for restructuring and insolvency professionals—overview. For a general primer on contractual debt claims, and in particular matters arising where the debt is disputed, see: Practice Note: Debt claims Practice Note: Starting a contractual debt claim — a practical guide Starting a contractual debt claim—checklist For a checklist covering key points for creditors contemplating a statutory demand, including general information on statutory demands from a dispute resolution angle, see: Making a statutory demand for dispute resolution...

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This Checklist outlines the principal considerations that respondents must address when replying to an imaging order. It should be read alongside the following Practice Notes: Search and imaging orders—guiding principles Search and imaging orders—making an application The model search and imaging order Search and imaging orders—execution of the order and next steps For guidance from the viewpoint of an applicant seeking an imaging order, see: Applying for an imaging order—checklist. 6 April 2025 changes With effect from 6 April 2025, the CPR provisions governing interim injunctive relief, including search and imaging orders, were amended. In particular, CPR 25 was extensively overhauled and the associated Practice Directions—covering the standard draft search order and the imaging order form (previously in Annex A and Annex B to Practice Direction 25A)—were revoked. In their place, a new model search and imaging order came into force on 6 April 2025 (the ‘model search and imaging...

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This Checklist sets out a recommended approach for dealing with and responding to a freezing injunction. It serves as a starting point, highlighting the key issues you should consider when preparing your response. It is assumed that: the freezing injunction was made pre-action and without notice; and your client is the defendant in the underlying substantive claim For further guidance on freezing injunctions generally, see the following Practice Notes: Freezing injunctions—guiding principles Freezing injunctions—the application Freezing injunctions—the draft order Ensuring you have all the necessary documentation The applicant should have provided, at the very least, the following documents: the application notice the affidavit(s) in support the sealed order a transcript of the hearing the skeleton argument (if one was used at the hearing) If any of the above are missing, request them from the...

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This checklist sets out a clear framework for dealing with a contractual debt claim at every stage: before issue on receipt of a letter of claim, and after issue on receipt of a claim form and particulars of claim. As a debtor facing a threatened or issued contractual debt claim, it can help to be aware of guidance directed at claimants (creditors), namely: Practice Note: Starting a contractual debt claim—a practical guide Starting a contractual debt claim—checklist Responding to a letter of claim Prior to starting court proceedings, the creditor ought to send a letter of claim that explains the debt and gives notice of the intended claim, whether the matter is governed by the Pre- Action Protocol for Debt Claims (the Protocol) or by the Practice Direction Pre- Action Conduct and Protocols (the Practice...

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This Checklist outlines various points a dispute resolution lawyer may wish to remember when advising a client who is responding to a claim pursued by a party facing financial difficulty. For broader guidance on matters to review at the outset of a dispute, see Practice Note: Resolving a dispute—initial considerations. For a checklist capturing a series of points which a dispute resolution lawyer may wish to bear in mind when assisting a client who is commencing or pursuing a claim against a party in financial difficulty, see: Advancing a claim against a party in financial difficulty—checklist. Claims brought by a claimant in financial difficulty In the event that you have doubts about the financial position of a (potential) claimant, there are several issues to reflect upon: Initial considerations Issue Considerations How do I determine the financial standing of a (potential) claimant? There are a variety of...

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CHECKLISTS

Special notice Under the Companies Act 2006 ( CA 2006), particular resolutions must be proposed with special notice in advance. Where such notice is required, a resolution is ineffective unless the company is given notice of the intention to propose it at least 28 days before the meeting at which it will be moved......

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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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