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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
Most recent Checklists
This Checklist This Checklist highlights the different avenues for bringing a joint venture ( JV) to a close or facilitating an exit, and the factors to weigh depending on the pathway chosen. For guidance on addressing a JV dispute, see Practice Note: Joint venture disputes—how to respond. For further detailed guidance on terminating joint ventures where a specially created or nominated joint venture company ( JVC) is involved, see the following Practice Notes: Termination—corporate joint ventures Tax implications of operating and terminating a joint venture company Corporate joint venture dispute—dealing with deadlock: initial considerations Majority-minority joint venture dispute—a practical illustration Entering a JV relationship usually calls for significant planning and effort from the JV parties, who opt to work together for mutual advantage (often by sharing cost, resources and expertise). You will need to assess the full...
Who to serve and when The respondent to the application is the Official Receiver or the relevant office-holder, and accordingly the application together with the witness statement must be served on them. Under the Insolvency ( England and Wales) Rules 2016 ( IR 2016), SI 2016/1024, r 22.2, the applicant must give notice of any application for permission to use a prohibited name to the Secretary of State for Business and Trade (the Secretary of State). This notification can be made via the Insolvency Service (for postal and email address details, see Insolvency Service Guidance: Re-use of company names). Rule 22.2 of IR 2016 requires that the Secretary of State receives no less than 14 days’ notice. In practice, however, notice ought to be provided to all interested parties as far ahead of any hearing as possible, in good time, so that the...
Scope and purpose This Checklist outlines the principal points to consider when preparing, assessing or agreeing an equipment hire agreement. Equipment hire agreements are also known as equipment leases, equipment rental, operating leases or finance leases. For simplicity, this Checklist adopts the term equipment hire agreement. It is written from the viewpoint of the hiring customer under the equipment hire agreement. See also the accompanying Precedents: Equipment hire agreement—pro-customer and Equipment hire agreement—pro-supplier. The Checklist highlights matters intended to safeguard the hiring customer’s (or lessee) interests in relation to an equipment hire agreement prepared by the supplier (or lessor) (as is typically the position with equipment hire agreements). Expressions such as ‘lessor’, ‘lessee’, ‘hirer’ and similar can be unclear within these sorts of arrangement. In this Checklist the ‘hiring customer’ or ‘lessee’ is the party taking the equipment on lease, and the...
The Environmental Permitting ( England and Wales) Regulations 2016 ( EPR 2016), SI 2016/1154 EPR 2016, SI 2016/1154 is the primary framework for environmental permitting and compliance, applying across diverse activities and industries. All offences taking place on or after 1 January 2017 are prosecuted under EPR 2016, SI 2016/1154. For information on environmental permitting generally, see: Environmental permits and exemptions—overview. For offences under EPR 2016, SI 2016/1154, the Environment Agency ( EA) and Natural Resources Wales ( NRW) may use a range of sanctions. The Regulations establish offences relating to: waste water quality groundwater radioactive substances Waste operations charges can be brought under EPR 2016, SI 2016/1154, or the Environmental Protection Act 1990 ( EPA 1990). Offences linked to water discharge activities or groundwater activities are commonly enforced through EPR 2016, SI 2016/1154, reg 38(1)(a), in respect of a breach of regulation 12(1)(b). See Practice Notes:...
Appointment of Receivers The Crown Court may, on the prosecutor’s application, appoint a receiver over a defendant’s realisable property where a confiscation order remains unsatisfied and is not under appeal. The court may grant the receiver the following powers in respect of that realisable property: power to take possession of the property power to manage or otherwise deal with the property, after hearing representations from those holding it power to realise the property, in such manner as the court directs, after hearing representations from those holding it power to commence, continue or defend any legal proceedings concerning the property Where the defendant’s realisable interest in the property is in dispute, it is not required that the property be shown to be the defendant’s proven realisable property (see eg Re Smith)......
Checklist for end-user licence agreement ( EULA) This Checklist aims to flag matters that often arise when drafting a business‑to‑business software end‑user licence agreement ( EULA), particularly where the software is licensed through a reseller. For more general guidance on key issues in software licensing generally, see Practice Note: Key issues in software licence agreements. For illustrative EULAs, review the following Precedents: ‘ Click-wrap’ software end‑user licence agreement ( EULA)—business‑to‑business ‘ Click-wrap’ software end‑user licence agreement ( EULA)—business to consumer Online terms and conditions for the supply of digital content and end user licence agreement—business‑to‑consumer For example software reseller agreements, see Precedents: Software reseller agreement and Software as a service ( Saa S) reseller agreement. As you work through the Checklist, the third column can be used to record observations or comments for...
When acquiring a leasehold property, it is vital to confirm that: the property benefits from all rights needed for access and for the authorised use; and any rights reserved over the premises are acceptable and will not unreasonably hinder occupation and use Problems may negatively affect the property's value and use and/or the buyer's ability to obtain finance, let, or dispose of it. See also: Due diligence—easements—checklist. Rights granted What rights have been granted to the tenant? Identify the tenant’s rights, which may comprise: express rights given to the tenant within the lease; and existing easements benefiting the landlord’s title that will also benefit the tenant’s title (unless the lease expressly excludes them) Are the granted rights sufficient for the tenant and the property? Consider whether the rights provided are adequate for the premises......
Use this Checklist when considering and reviewing a registered title as part of the due diligence process. It presumes the title is being assessed in the context of a proposed purchase of the property; however, identical considerations arise when due diligence is undertaken in relation to taking a registered charge over the property, or when negotiating and entering into a new lease of the property. For land that is unregistered, refer to Practice Notes: Deducing title to unregistered land—compulsory first registration, party to register, evidence of title, good root of title and unbroken chain of ownership; and Deducing title to unregistered land—stamp duty, mortgages, execution of documents, missing title deeds, sales of part and other considerations. Have official copies of the register and plan been provided? Official copies—register and plan For registered land, title is shown by supplying current official copies of the register and plan. They must be...
This flowchart details the actions to follow when enhancing a procedure in your firm, highlighting relevant Precedents associated with every stage...
Use this Checklist when carrying out a due diligence exercise for the acquisition of commercial property intended for investment purposes within an investment context. In any such review of an investment purchase, ensure advice addresses the terms governing any rent deposits held by the landlord in respect of occupational tenancies. A rent deposit provides security for an occupational tenant’s obligations, so any and all concerns over the landlord’s ability to draw on the deposit where the tenant is in default should be examined very carefully and fully reported to the buyer. See also Practice Note: Rent Deposit Deeds— Commercial Leases. What are the key points to check in due diligence?......
This checklist is intended for use in a due diligence process where a purchaser, tenant or lender is examining title to property that is burdened by, or enjoys the benefit of, positive covenants. It sets out the relevant matters to consider when reviewing and reporting on positive covenants. Are there any positive covenants affecting the property? A positive covenant is a commitment to perform an act or to make a financial contribution to something. Typical examples in property transactions include covenants to erect and keep in repair a fence, or to contribute towards the upkeep of a shared driveway or other communal facilities. HM Land Registry has no duty or authority to record the benefit of a positive covenant on a registered title......
This flowchart outlines actions to follow for enhancing a procedure in your firm, and points to Precedents linked to every stage...
This Checklist is for use as part of a due diligence exercise when reviewing an option to renew a lease. It is chiefly directed at a buyer of a reversionary interest in the lease that includes the option, though it also flags matters a buyer of leasehold property benefiting from an option should consider. Ask whether the option gives rise to a perpetually renewable lease. Confirm the renewal provision clearly states the new lease will not itself include a further option to renew. Where each renewal lease carries another option, a perpetually renewable lease is created. A perpetually renewable lease is converted into: in the case of a head lease, the grant of a lease for 2,000 years; and in the case of an underlease, the grant of a lease for a term ending one day before the expiry of the term from which it is...
Checklist During any due diligence for buying investment property subject to leases, a purchaser must determine if any guarantees from previous tenants or guarantors continue to subsist. This Checklist, although not comprehensive, outlines essential actions and points for review to assess whether, in practice, a past tenant or guarantor retains ongoing liability in respect of breaches committed by the present tenant. The legal framework governing former tenants and guarantors varies according to whether the lease qualifies as a new tenancy or an old tenancy for the purposes of section 1 of the Landlord and Tenant ( Covenants) Act 1995 ( LT( C) A 1995), as applicable. Leases granted on or after 1 January 1996 are treated as new tenancies, save for: leases granted pursuant to an agreement for lease or a court order made before that date leases granted pursuant to an option or a...
This Flowchart sets out the conditions that must be satisfied for the court to declare that a transaction constitutes a preference and grant relief. This diagram outlines the criteria that need to be met for the court to find a transaction is a preference and award appropriate relief......
This flow chart outlines the criteria for a specific creditor-defrauding transaction...
This Flowchart sets out the requirements for a transaction defrauding creditors. This flow chart explains the requirements for a transaction defrauding creditors......
Flowchart The diagram outlines the criteria that must be met for the court to determine a transaction occurred at an undervalue and to provide appropriate relief......
This Flowchart This Flowchart outlines the criteria that must be met for the court to determine that a transaction amounts to a preference and award relief......
Flowchart This flowchart outlines the requirements that need to be met to found a wrongful trading claim...
Popular documents
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 ]...
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