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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
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This checklist outlines recommended actions and practical steps that a local authority ( LA) could take to avoid the undue build-up of social care debt by service users. Prevention Preventing the accumulation of debt is the crucial priority. Below are proposed measures for the client department of an LA to adopt so liabilities do not progress to formal legal action, or to make early recovery activity simpler: Gather thorough details at the outset of the process. Obtain as much financial evidence as possible, including copies of bank statements, DWP correspondence, and so on......
This Checklist sets out a concise overview of the applicable law on deferred payment agreements ( DPAs), identifying when they must be granted, how to select and establish the DPA, the steps for execution and managing mandatory signatories who lack capacity, together with registering the agreement and keeping originals once registration is complete. Deferred payment agreements—relevant law Your first points of reference for deferred payment agreements ( DPAs) are the statute, regulations and guidance. These are: sections 34 and 35 of the Care Act 2014 ( CA 2014) the Care and Support ( Deferred Payment) Regulations 2014, SI 2014/2671 Part 9 of the Care and support statutory guidance (the guidance) Points to note This Checklist covers offering and securing mandatory DPAs, namely DPAs which legislation and regulations compel you to agree to. It does not address the...
Checklist This Checklist outlines the details to be included in a Notice of Urgent Modification for submission to UK central digital platform, ensuring compliance with the transparency obligations imposed by the Health Care Services ( Provider Selection Regime) Regulations 2023 ( PSR Regs 2023), SI 2023/1348, as specified in regulation 14(5)(c), Schedule 14......
This Checklist This Checklist identifies the details that must be included within a Notice of Urgent Award, for submission to the UK central digital platform, in order to meet the transparency obligations prescribed by the Health Care Services ( Provider Selection Regime) Regulations 2023 ( PSR Regs 2023), SI 2023/1348, reg 14(5)(b), Sch 13......
Checklist This Checklist outlines the details that must appear in a notice of intention of intention to make an award, or to finalise a framework agreement, with the Chosen Provider through the Competitive Process, intended for submission to the UK central digital platform, to satisfy the transparency requirements set and mandated by the Health Care Services ( Provider Selection Regime) Regulations 2023 ( PSR Regs 2023), SI 2023/1348, reg 11(10), Sch 10......
This checklist outlines the particulars that must be set out in a notice of intention to use the Most Suitable Provider Process, for submission to the UK central digital platform, to meet the transparency obligations prescribed by the Health Care Services ( Provider Selection Regime) Regulations 2023 ( PSR Regs 2023), SI 2023/1348, reg 10(3). Information to be included A declaration that the relevant authority plans to follow the Most Suitable Provider Process to award a contract Contract title and reference The name and address of the registered office or principal place of business of the provider to whom an award is to be made Description of the relevant health care services, including the most relevant CPV code Details of the award...
This Checklist This Checklist explains the particulars that must appear in a notice to be submitted to the UK central digital platform to satisfy the applicable transparency duties imposed by the Health Care Services ( Provider Selection Regime) Regulations 2023 ( PSR Regs 2023), SI 2023/1348, reg 9(4), Sch 3, following the direct award made of a health care contract under Direct Award Process C......
This checklist sets out the details required in a notice of intention to award to the Chosen Provider under the Most Suitable Provider Process, for submission to the UK central digital platform, to meet the transparency duties in the Health Care Services ( Provider Selection Regime) Regulations 2023 ( PSR Regs 2023), SI 2023/1348, reg 10(8), Sch 6. Information to be included A declaration that the authority intends to award via the Most Suitable Provider Process Contract title and reference Registered office or principal place of business of the provider awarded Description of the health care services, including the most relevant CPV code Estimated lifetime value of the contract Details of the award decision-makers An explanation of the decision-makers’ reasons for selecting the chosen provider with reference to key criteria Any declared or potential...
Checklist This Checklist outlines the details that must appear in a notice concerning a contract or framework agreement change, which must be submitted to the UK central digital platform to meet the transparency obligations imposed under the Health Care Services ( Provider Selection Regime) Regulations 2023 ( PSR Regs 2023), SI 2023/1348, reg 13(b), Sch 12......
Information to be included This checklist explains the details that must be set out in a notice submitted to the UK central digital platform to satisfy the transparency obligations in the Health Care Services ( Provider Selection Regime) Regulations 2023 ( PSR Regs 2023), SI 2023/1348, reg 9(11)(a), following a direct award of a health care contract using Direct Award Process C. A clear statement that the award was made using Direct Award Process C Contract title and reference The provider’s name and the address of its registered office or principal place of business A description of the relevant health care services, including the most appropriate CPV code The lifetime contract value or, if not yet known, the sums payable to the provider under the contract The dates during which the services will be delivered Details of the award...
This Checklist This Checklist outlines the details that must feature in a notice of intention to award to the Chosen Provider within the Most Suitable Provider Process, for submission to the UK central digital platform, ensuring adherence to transparency obligations set by the Health Care Services ( Provider Selection Regime) Regulations 2023 ( PSR Regs 2023), SI 2023/1348, reg 11(4), Sch 8, in full compliance......
This Checklist This Checklist describes the information that must be included in a notice to be sent to the UK central digital platform, to ensure compliance with transparency requirements mandated by the Health Care Services ( Provider Selection Regime) Regulations 2023, SI 2023/1348, reg 10(15)(a), Sch 7, following an award under the Most Suitable Provider Process......
Information to be included This Checklist summarises the particulars that must be set out in a notice issued after a competition under the Competitive Process, for submission to the UK central digital platform, to satisfy the transparency duties in the Health Care Services ( Provider Selection Regime) Regulations 2023 ( PSR Regs 2023), SI 2023/1348, reg 11(17) and Sch 11... Confirmation that the award results from a Competitive Process. Contract or framework title and reference. Name and registered office or main business address of the successful provider. Summary of the relevant health care services and the most appropriate CPV code (see PSR Regs 2023, SI 2023/1348, Sch 1). Estimated lifetime contract value, or amounts payable if unknown. For a framework: duration, eligible relevant authorities, and total lifetime value. For a contract: the service provision start and end...
What is neurodiversity? Neurodiversity is a collective term covering conditions like ADHD, the autism spectrum, dyscalculia, dyslexia and dyspraxia, which influence how someone experiences and engages with the world. Sensory stimuli can be overpowering for people with these profiles. Yet many are exceptionally bright when they can operate in ways that align with how their brain works. Society is increasingly recognising that it should adapt to include neurodiverse people, rather than expecting them to reshape themselves to fit in, so that they can participate fully in community life. These conditions are more prevalent than many realise and are often unidentified because individuals have learned to mask. Firms are placing greater focus on inclusion and diversity, and this checklist is intended to help them review their environment and make it as comfortable as possible for all...
ARCHIVED: This archived checklist outlines the actions a military reservist must follow regarding becoming a reservist or moving to a new employer, alongside training, mobilisation, and demobilisation. For guidance on a reservist’s rights and duties, refer to Practice Note: Military reservists. For an employer-focused checklist, consult: Checklist for employer of military reservist for additional background and context as required......
REMEMBER: The 42-day appeal deadline finishes at 4pm on the 42nd day. It is YOUR duty to ensure ALL required papers are submitted within that period. DO NOT LEAVE IT UNTIL THE LAST MINUTE. If your appeal is missing documents or pages, it is classed as ‘not properly instituted’, meaning it has not been correctly lodged. The Checklist Read sections 1 to 3 of the EAT Practice Direction 2024 and the T440 Guidance. Notice of Appeal: have you completed every section of the Notice of Appeal from decision of Employment Tribunal ( Form T444)?......
Introduction This Checklist is intended for legal representatives who are involved in directly assisting witnesses to prepare trial witness statements within the Business and Property Courts, and which are subject to CPR PD 57AC. This Checklist should be read alongside Practice Note: Trial witness statements in the Business and Property Courts under CPR PD 57AC, which sets out the requirements in fuller detail......
This checklist summarises the details that must appear in an invitation issued to providers that are party to the framework agreement to submit an offer, in order to meet the transparency duties required by the Health Care Services ( Provider Selection Regime) Regulations 2023 ( PSR Regs 2023), SI 2023/1348, reg 18(8), Sch 15. Information to be included Summary of the relevant health care services, identifying the most appropriate CPV code. Contract award criteria. Proposed or indicative dates for service delivery and the contract duration, including any options to extend beyond the initial term. Approximate lifetime value of the contract or framework agreement. Further reading PSR Regs 2023, SI 2023/1348, Sch 1 and Practice Note: Health care procurement under the Provider Selection Regime— What services fall within the scope of the PSR? Practice Note: Health care...
This Checklist summarises the steps to be taken by the employer of a military reservist in relation to first employing a reservist, training, mobilisation and demobilisation. For comprehensive guidance on an employer’s responsibilities and duties concerning a military reservist employee, please consult Practice Note: Military reservists. For a checklist intended for the reservist employee’s own use, see: Checklist for military reservist [ Archived]......
This Checklist outlines the requirements for selecting or appointing negotiating representatives for the purposes of the Information and Consultation of Employees Regulations 2004 ( ICER 2004), SI 2004/3426. For broader guidance on representatives under ICER 2004 generally, see Practice Note: ICER employee representatives. For further guidance on ICER 2004, refer to Practice Note: The Information and Consultation of Employees Regulations 2004. Government guidance issued in 2006 has been archived but remains a useful source, particularly as the regulations themselves offer limited detail on the matters addressed in this Checklist. See also the Acas guidance on informing and consulting on workplace matters. General requirements Following a valid employee request, the employer must, as soon as reasonably practicable, put in place arrangements enabling employees to appoint or elect negotiating representatives to negotiate the information and consultation arrangements to be...
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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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