GLOSSARY
Database definition
What does Database mean?
A database is a copyright work which comprises a collection of independent works, data or other material which are arranged in a systematic way and are individually accessible by electronic or other means.
An original database is a literary work and so protected as a copyright work provided that by reason of the selection or arrangement of the contents of the database the database constitutes the author's own intellectual creation. See Copyright, Designs and Patents Act 1988, s 3A.
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Telecoms, wireless—at-a-glance industry guide for commercial lawyers
Telecoms, wireless—at-a-glance industry guide for commercial lawyers Mobile networks This Practice Note provides an introductory at-a-glance guide to the wireless telecoms industry for commercial lawyers. Mobile electronic communications networks are often known as cellular networks. This is because they are made up of a tessellation of cells, designed so that the network can use its allocated frequency spectrum in the most efficient way possible. A cell is defined as the area of coverage of a base station (BS), with adjacent cells using different frequencies to minimise channel interference. Cells in rural areas cover a larger area than in built-up areas, where more capacity is required. GSM networks Global System for Mobile communications (GSM—this is a backronym, as technically GSM is the Groupe Spécial Mobile) is the most ubiquitous network standard. GSM is known as 2G (second generation, the first being analogue mobile networks). 2G continues to develop from the system first deployed in 1991, with the introduction of packet data capability standard, General Packet Radio Service (GPRS) in 1997 (hence 2.5G) and with enhanced packet data possible from 1999 with the Enhanced Data Rates for GSM Evolution (EDGE) standard (hence 2.75G, although sometimes claimed to be a 3G technology—see below). GPRS enables data transmission of rates from 56 to 114 kbit/s, whereas EDGE gives up to 236.8 kbit/s (with a theoretical maximum of 473.6 kbit/s). The 2G base station controls the
Worker and Temporary Worker sponsor duties: preparing for and attending a Home Office visit
Worker and Temporary Worker sponsor duties: preparing for and attending a Home Office visit When can the Home Office visit an organisation (or a related third party)? The Home Office is able to carry out compliance visits to the premises of licensed sponsors, or any site under the sponsor's control, at any time, whether announced or unannounced. It may also want to visit addresses where sponsored employees will be or are working (which could include the premises of a third party). Where this may be relevant, they will want to see evidence of arrangements between the sponsor and the third party that would ensure full co-operation by the third party. It is the sponsor’s responsibility to ensure that the third party is aware of the possibility of unplanned and unannounced visits and checks being conducted at their premises, and to ensure their full co-operation. A visit could be undertaken as part of the Home Office's pre-licence checks on an applicant organisation (including where a sponsor is seeking to add a new route to its licence), or following an application to renew a licence or report/notification it has provided to the Home Office. It may also occur where the Home Office has concerns that a sponsor is complying with its duties and responsibilities, eg where it has received intelligence/allegations on a particular issue. A sponsor's ability to be visited
State aid—Norway—Q&A guide [Archived, 2021 edition]
State aid—Norway—Q&A guide [Archived, 2021 edition] This Practice Note contains a jurisdiction-specific Q&A guide to state aid in Norway published as part of the Lexology Getting the Deal Through series by Law Business Research (published: March 2021). Authors: Arntzen de Besche Advokatfirma AS—Svein Terje Tveit; Torjus Midthun Otterbech 1. Outline your jurisdiction’s state aid policy and track record of compliance and enforcement. What is the general attitude towards subsidies in your system? Norway has a strong public sector, and the Norwegian state is relatively active and involved in the market through public ownership, regulations, direct subsidies and other forms of state aid, as exemplified now in a time of crisis (the covid-19 pandemic). Services of general economic interest (SGEI) are a popular tool currently applied in sectors such as transport, broadcasting, healthcare, public infrastructure and culture. Norwegian and EEA state aid enforcement is, nevertheless, still at a fairly low level compared with EU member states. The European Free Trade Association (EFTA) Surveillance Authority (ESA) had adopted 72 decisions as at 25 March 2021 (56 relating to the covid-19 pandemic), 13 decisions in 2019, six decisions in 2018, 14 decisions in 2017, 17 decisions in 2016, 19 decisions in 2015 and 21 decisions in 2014 respectively concerning state aid in Norway. Further, there has been a sharp rise in cases notified under the General Block Exemption Regulation (GBER) to
Environmental issues in the supply chain for commercial lawyers
Environmental issues in the supply chain for commercial lawyers Chemicals As a business customer, when drafting a supply agreement for the purchase of chemical substances, what specific chemical sector legislation may apply to the transaction which the supplier must comply with? Does the business customer attract any obligations? UK REACH UK REACH applies to the manufacture, placing on the GB market or use of chemical substances on their own, in mixtures or in articles.Where a substance is manufactured or imported into GB in quantities of one tonne or more per year then the substance must be registered on a database managed by the HSE, unless an exemption applies. Failure to register means that the substance cannot be placed on the market in GB. For more information, see Practice Note: UK REACH—registration.UK REACH provides for evaluation of registered substances by the Health and Safety Executive (HSE). Substances that meet certain hazard criteria may be subject to authorisation: a process in which particular uses of that substance require authorisation in advance. In addition, companies producing, importing or selling articles containing certain Substances of Very High Concern (SVHCs) in a concentration above 0.1% weight by weight (and in the case of complex articles, the 0.1% w/w threshold applies to each individual article that makes up the complex article) must submit information on
Applying to naturalise as a British citizen: eligibility
Applying to naturalise as a British citizen: eligibility Naturalisation is the most common way for adults to acquire British citizenship. The naturalisation route to British citizenship enables adults who do not fulfil automatic registration criteria but who have lived in the UK for specified periods to apply to become a British citizen. A person who becomes a British citizen through naturalisation is considered a British citizen otherwise than by descent. The current legal framework governing the criteria under which an application for naturalisation can be made is set out in the British Nationality Act 1981 (BNA 1981). BNA 1981, s 6 and Sch 1 set out a series of requirements, some of which are compulsory and others of which are subject to an exercise of discretion on the part of the Secretary of State for the Home Department (SSHD) to disregard. The requirements for naturalisation are different for an applicant who is married to, or in a civil partnership with, a British citizen, or who is in Crown service overseas or married to a British citizen in such service. Naturalisation, unlike registration, is not an entitlement. The grant of a certificate of naturalisation is at the discretion of the SSHD. Under BNA 1981, s 6, the SSHD may grant a certificate of naturalisation to a person of full age and
EU REACH—evaluation, authorisation and restrictions
EU REACH—evaluation, authorisation and restrictions Originally produced by WSP Parsons Brinckerhoff. Update produced in partnership with Anthesis Brexit 11 pm (GMT) on 31 December 2020 marked the end of the Brexit transition/implementation period entered into following the UK’s withdrawal from the EU. At this point in time (referred to in UK law as ‘IP completion day’), key transitional arrangements came to an end and significant changes began to take effect across the UK’s legal regime. From IP completion day, EU REACH no longer applies in Great Britain. In Great Britain, a new regime, UK REACH applies. For more information, see Practice Note: Brexit—chemicals and hazardous substances—REACH. Introduction to REACH 'REACH' is an abbreviated term for Regulation (EC) 1907/2006 of the European Parliament and of the Council concerning the registration, evaluation, authorisation and restriction of chemicals (REACH Regulation). The REACH Regulation has been amended a number of times since coming into force, and furthermore several pieces of implementing legislation have been introduced to ensure its operation, see: Europa. REACH came into force on 1 June 2007 to replace a number of European Directives and Regulations with a single piece of legislation and applies directly within all the Member States of the EU. Prior to the introduction of REACH, there had been concern that the risks presented by chemicals being used and marketed in the EU were not being adequately
EU REACH—substances in mixtures and articles
EU REACH—substances in mixtures and articles Brexit 11 pm (GMT) on 31 December 2020 marked the end of the Brexit transition/implementation period entered into following the UK’s withdrawal from the EU. At this point in time (referred to in UK law as ‘IP completion day’), key transitional arrangements came to an end and significant changes began to take effect across the UK’s legal regime. From IP completion day, EU REACH no longer applies in Great Britain. In Great Britain, a new regime, UK REACH applies. For more information, see Practice Note: Brexit—chemicals and hazardous substances—REACH. Background to REACH The REACH regime regulates chemical substances, mixtures and articles within the EU. Regulation (EC) 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (the REACH Regulation) came into force on 1 June 2007. The REACH Regulation applies to all substances (including those in mixtures and in articles) which are manufactured or imported into the EU in quantities of one tonne or more per year. For more information, see: • REACH—overview • Practice Notes: ◦ EU REACH—objectives and scope ◦ EU REACH: Regulation 1907/2006—snapshot Overview of REACH The REACH regime stands for the registration, evaluation, authorisation and restriction of chemicals and is regulated at the EU level by the European Chemicals Agency (ECHA). The aim of REACH is to ensure that
Use of attestations by the FCA and the PRA
Use of attestations by the FCA and the PRA Financial Services Enforcement Database: This incorporates detailed information on all substantive FCA and PRA Final Notices and, where available, Decision Notices from 2014 to 2022. The Database, available here, may be searched and filtered by rule breach, keyword, sector, date, seriousness, aggravating and mitigating factors, financial penalty, and other actions such as appeals. What is an attestation? The Financial Conduct Authority (FCA) and Prudential Regulation Authority (PRA) may request an attestation from a firm where they are concerned about (or investigating) an actual or potential breach of regulatory requirements. Broadly speaking, an attestation is a request from the regulator to an individual at a regulated firm (usually a member of management who is also a Senior Manager) that they provide a signed, written confirmation of the firm’s compliance with a regulatory requirements in relation to a particular aspect of the business. The FCA issued guidance in the form of a letter to the FCA Practitioner Panel in August 2014 on the use of attestations (the Attestation Letter), to clarify its views on when it expects to use attestations and the outcomes it wants to achieve. The PRA also uses attestations as a routine supervisory tool (generally using standard forms), although it has stated that it can require attestations as to compliance with specific
Introduction to utilities contracts procurement
Introduction to utilities contracts procurement Brexit impact—public and utilities procurement The UK public and utilities procurement regime derives from EU public procurement laws, and was therefore impacted by the UK’s withdrawal from the EU; but only to a limited extent. In all material respects, the public procurement regime in the UK continues with minimal changes. The Public Procurement (Amendment etc.) (EU Exit) Regulations 2020 amended and revoked provisions of public/utilities procurement legislation in order to address practical issues arising due to the UK’s withdrawal from the EU, ensuring that the legislation would continue to operate effectively after the UK left the EU and the associated transitional arrangements came to an end at the end of the Brexit transition/implementation period at 11 pm on 31 December 2020 (IP completion day). These amendments formed part of the wider domestic legislative project in connection with Brexit, introduced under the European Union (Withdrawal) Act 2018 (EU(W)A 2018). Some of these amendments are subject to overriding requirements in line with the UK’s international obligations, for instance under relevant separation provisions of the Withdrawal Agreement, or under the procurement provisions within the EU-UK Trade and Cooperation Agreement (TCA). For background reading, see Practice Notes: Brexit—key legislation explained and Brexit—the implications for public procurement. The aim of the amendments to the various pieces of
Introduction to the EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
Introduction to the EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation This Practice Note provides an overview of Regulation (EU) 2017/745, the Medical Devices Regulation (MDR) and Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation (IVDR), and the process for placing a device on the EU market. For further information on: • scope and classification of devices, conformity assessment procedures and Notified Bodies, see Practice Note: The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—scope, classification of devices and Notified Bodies • clinical evaluation and investigation of devices, see Practice Note: Clinical evaluation and performance evaluation of medical devices in the EU • post-market surveillance, see Practice Note: Post-market surveillance of medical devices in the EU • European database on medical devices (EUDAMED) and the obligations of economic operators, see Practice Note: The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—EUDAMED and economic operators Legislative framework EU Directives Until 25 May 2021 medical devices and active implantable medical devices (AIMDs) within the EU/EEA were regulated by the following directives: • Directive 93/42/EEC on Medical Devices (MDD) • Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDD) governed in vitro diagnostic medical devices
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Website terms and conditions of use
Website terms and conditions of use 1 About our terms 1.1 These terms and conditions of use (Terms) explain how you may use this website and any of its content (Site). These Terms apply between [insert name of website operator] (we, us or our) and you, the person accessing or using the Site (you or your). 1.2 You should read these Terms carefully before using the Site. By using the Site or otherwise indicating your consent, you agree to be bound by these Terms. If you do not agree with any of these Terms, you should stop using the Site immediately. 1.3 [The Site is provided by us to you free of charge for information[ or entertainment] purposes only. OR These Terms apply to any parts of the Site, its functionality and content provided to you free of charge for information[ or entertainment] purposes only.] 1.4 If you order any goods, services or digital content from the Site[ or if you buy a subscription or membership to access restricted parts of the Site], separate terms and conditions will apply[ as set out here [insert relevant details eg relevant T&Cs hyperlink]]. 1.5 [If you would like these Terms in another format (for example: audio, large print, braille), please contact us using the contact details set out below.] 2 About us 2.1 We are [insert name of website operator][ (trading as [insert trading name])], a company
Sales and marketing agency agreement for services—non-exclusive—pro-agent
Sales and marketing agency agreement for services—non-exclusive—pro-agent This Agreement is made on [date] Parties 1 [insert name of party] [of OR a company incorporated in [England and Wales] under number [insert registered number] whose registered office is at] [insert address] (Principal); and 2 [insert name of party] [of OR a company incorporated in [England and Wales] under number [insert registered number] whose registered office is at] [insert address] (Agent), (each of the Principal and the Agent being a party and together the Principal and the Agent are the parties). Background (A) The Principal supplies the Services (as defined below). (B) The Principal wishes to appoint the Agent as its non-exclusive agent in the Territory (as defined below) for the [marketing OR marketing and sale] of the Services on the terms of this Agreement. (C) The Agent has agreed to [market OR market and sell] the Services in the Territory on the Principal’s behalf on the terms of this Agreement. The parties agree: 1 Definitions and interpretation 1.1 In this Agreement, unless otherwise provided: Affiliate • means any entity that directly or indirectly Controls, is Controlled by, or is under common Control with, another entity; Agreement • means the main body of this Agreement, its schedules and appendices, as each may be amended from time to time in accordance with their terms; Bribery Laws • means the Bribery Act 2010; Business Day • means a day other than
Share purchase agreement—pro-buyer—individual sellers—conditional—long form
Share purchase agreement—pro-buyer—individual sellers—conditional—long form This Agreement is made on [insert day and month] 20[insert year] Parties 1 The several persons whose names and addresses are set out in Schedule 1 (together the Sellers), and 2 [Insert name of purchasing corporate entity] incorporated in [England and Wales OR [Insert country of incorporation]] with registered number [insert company number] whose registered office is at [insert address] (the Buyer), [(each of the Sellers and the Buyer being a Party and together the Sellers and the Buyer are the Parties).] Background (A) The Company (as defined below) is a private company limited by shares and is incorporated in[ England and Wales OR [insert country of incorporation]]. Details of the Company are set out in Schedule 2, Part A. (B) The Sellers are the legal and beneficial owners of the Sale Shares (as defined below), being in aggregate the entire allotted and issued share capital of the Company. (C) The Sellers have agreed to sell and the Buyer has agreed to purchase the Sale Shares on the terms of this Agreement. The parties agree: 1 Definitions and interpretation 1.1 In this Agreement[ unless the context otherwise requires]: Accounts • means the audited accounts of[ the Company OR each Group Company and the audited consolidated accounts of the Group] [ for the accounting reference period ended on the Accounts Date OR for each of the last [insert number] consecutive accounting
API terms of use
API terms of use IP COMPLETION DAY: The Brexit transition period ended at 11pm on 31 December 2020. At this time (referred to in UK law as ‘IP completion day’), transitional arrangements ended and significant changes began to take effect across the UK’s legal regime. This document contains guidance on subjects impacted by these changes. Before continuing your research, see Practice Note: What does IP completion day mean for TMT? Please read these api terms of use carefully before using the api. By using the api, you agree to be bound by these api terms of use. If you do not agree to these api terms of use you must not use our api for any purpose whatsoever. In these API Terms of Use, We, Our, Ourselves, Us or API Licensor means [insert company name] (a company incorporated in [England and Wales] under number [insert registered company number] whose registered office is at [insert address]) and You, Your or API Licensee means you (and if you are using the API on behalf of a legal person, business or other organisation (Organisation) includes you and also such Organisation). By using the API on behalf of any Organisation, You represent and warrant (promise) that You have all necessary capacity and authority to enter into these API Terms of Use on behalf of such Organisation as a legally
Mobile application development agreement—pro-customer
Mobile application development agreement—pro-customer This Agreement is made on [insert date] (the Commencement Date) between the following: Parties 1 [insert supplier name] a company incorporated in England and Wales whose registered number is [insert company number] and whose registered office is at [insert registered office] (Supplier); and 2 [insert customer name] a company incorporated in England and Wales whose registered number is [insert company number] and whose registered office is at [insert registered office] (Customer), each of the Supplier and the Customer being a party and together the Supplier and the Customer are the parties. Background (A) The Supplier is [an experienced developer of mobile applications and] [insert the Supplier’s background details and the background to the relevant transaction]. (B) The Customer is [insert the Customer’s background details]. (C) The Supplier wishes to develop the Mobile App (as defined below) and the Customer wishes to engage the Supplier to develop the same on the terms of this Agreement. The parties agree: 1 Definitions and interpretation 1.1 Words shall have the meanings given to them in this Agreement, including without limitation as set out below: Acceptance • means the successful completion of all Acceptance Criteria for all Acceptance Tests; Acceptance Criteria • means, in relation to an Acceptance Test, the criteria which must be met for that Acceptance Test to be successfully completed as set out in Schedule 9; Acceptance Tests • means the mutually agreed tests in accordance
Letter of claim—database right infringement
Letter of claim—database right infringement Letter of claim [Alleged infringer’s name and address] [Date] Dear [insert organisation name] [Copyright and] database right infringement: [Name and description of database] We are writing on behalf of [name of client] of [address]. We are writing to you about your activities and actions, which amount to an infringement of our client’s [copyright and] database right. [Name of client] [Name of client] operates in [describe the industry of operation, what the rights owner does, who in the company makes, produces and maintains the database and, if relevant how, they are employed. Define or give the name of the database (Database)]. [Name of client] is the [owner OR owner-assignee OR non-exclusive licensee OR exclusive licensee] of [copyright and] database right in the database, an extract of which is enclosed for your attention. [In accordance with section 11(2) of the Copyright, Designs and Patents Act 1988 (CDPA 1988) and the Copyright and Rights in Databases Regulations 1997, SI 1997/3032, Regulation 14(2) our client owns the copyright subsisting in the Database because it is the employer of the person(s) who produced and/or made the Database.] The database [Our client’s [defined Database] is protected under copyright law as an original literary work under section 3(1) of the CDPA 1988.] [Our client employs highly skilled and experienced [name of type of employees, eg analysts] who use
Legal due diligence questionnaire—private M&A—share purchase
Legal diligence'>due diligence questionnaire—private M&A—share purchase Dated [insert date] Introduction This legal due diligence questionnaire relates to the proposed purchase by [insert buyer name] (the Buyer) of the entire issued share capital of [insert name of target company] Limited incorporated in England and Wales under number [insert company number] (the Company) from [insert seller name] (the Seller) (the Proposed Acquisition). This questionnaire is designed to enable the Buyer, the Buyer's solicitors and other professional advisers involved in the Proposed Acquisition to obtain the information which the Buyer requires to assist in its valuation of the Company. Please answer every question fully. Please provide your answers in italics underneath each question and provide copies of all relevant documentation, ensuring that all answers and documents are clearly marked by reference to the appropriate paragraph of this questionnaire. We reserve the right to raise further enquiries in respect of both your responses to this questionnaire and generally. Definitions Business • means the business of [insert description of the business] and all other activities including those ancillary or incidental to or in connection with such business as carried on by the [Company OR Group] CA 2006 • means the Companies Act 2006; Contractor • means any individual working in a Group Company’s business who is not an Employee or Worker; Data Protection Laws • means
Share purchase agreement—pro-buyer—corporate seller—conditional—long form
Share purchase agreement—pro-buyer—corporate seller—conditional—long form This Agreement is made on [insert day and month] 20[insert year] Parties 1 [Insert name of selling corporate entity] incorporated in [England and Wales OR [insert country of incorporation] OR with registered number [insert company number] whose registered office is at [insert address] (the Seller); 2 [Insert name of purchasing corporate entity] incorporated in England and Wales OR [insert country of incorporation] OR with registered number [insert company number] whose registered office is at [insert address] (the Buyer), and 3 [Insert name of guarantor entity] incorporated in England and Wales OR [insert country of incorporation]] with registered number [insert company number] whose registered office is at [insert address] (the Guarantor) [(each of the Seller, the Buyer and the Guarantor being a Party and together the Seller, the Buyer and the Guarantor are the Parties).] Background (A) The Company (as defined below) is a private company limited by shares and is incorporated in [England and Wales OR [insert country of incorporation]]. Details of the Company are set out in Schedule 1. (B) The Seller is the legal and beneficial owner of the Sale Shares (as defined below), being in aggregate the entire allotted and issued share capital of the Company. (C) The Seller has agreed to sell and the Buyer has agreed to purchase the Sale Shares on the terms of this Agreement. (D) The Guarantor
Franchise business sale agreement
Franchise business sale agreement This Agreement is made on [insert date] 20[insert year] Parties 1 [insert name] [of OR incorporated in [insert jurisdiction, eg England and Wales] under number [insert company number] whose registered office is at] [insert address] (the Seller); 2 [insert name] [of OR incorporated in [insert jurisdiction, eg England and Wales] under number [insert company number] whose registered office is at] [insert address] (the Buyer); and 3 [insert name] [of OR incorporated in [insert jurisdiction, eg England and Wales] under number [insert company number] whose registered office is at] [insert address] (the Franchisor), (each a party and together the parties). Background (A) The Franchisor has licensed the Seller to operate the Franchise Business. (B) The Seller has agreed to sell and the Buyer has agreed to purchase the Franchise Business as a going concern on the terms and conditions of this Agreement. The parties agree: 1 Definitions and interpretation 1.1 In this Agreement: Applicable Data Protection Law • means any applicable law relating to the processing, privacy and/or use of Personal Data, as applicable to either party or the Business, including: (a) the GDPR; (b) the Data Protection Act 2018; (c) any laws which implement any such laws; (d) any laws that replace, extend, re-enact, consolidate or amend any of the foregoing; and (e) [all guidance, guidelines and codes of practice issued by any relevant Data Protection Supervisory Authority relating to such Data Protection
Policy—social media
Policy—social media 1 Introduction 1.1 The Company recognises that the internet and social media platforms are used as a means of communication both at work and at home. This policy outlines the standards we require staff to observe when using social media, the circumstances in which the Company will monitor use of social media and the action we will take if this policy is breached. This policy should be read in conjunction with our [Internet, email and communications policy], which sets out how the Company’s internet and email systems and networks can be used by our staff and representatives. 1.2 This policy applies to all individuals, including employees, workers, temporary and agency workers, contractors, interns, volunteers and apprentices (referred to as ‘staff’ in this policy). 1.3 Staff should refer to the Company’s [data protection privacy notice] and, where appropriate, to its other relevant policies including in relation to [data protection, equality, harassment and bullying, and information security]. 1.4 [This policy has been drafted with the assistance of a representative group of employees to ensure that it is clear and easy to understand. ]We will review and update this policy regularly to take account of changes in technology, legal obligations and best practice. Except where expressly stated, this policy is non-contractual and we may amend, update or supplement it at any time. We will circulate any new or modified policy
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Are you aware of any databases for: (i) a European regulatory body for medical devices for human application from which technical information about devices seeking approval can be obtained, (ii) obtaining a copy of the application if a medical device manufacturer has applied for authorisation for use in Europe? In the US, medical device manufacturers must submit a detailed application to the Food and Drug Administration (FDA). The application to the FDA is referred to as ‘510K’ filing. Is there a European equivalent where such information can be found?
Are you aware of any databases for: (i) a European regulatory body for medical devices for human application from which technical information about devices seeking approval can be obtained, (ii) obtaining a copy of the application if a medical device manufacturer has applied for authorisation for use in Europe? In the US, medical device manufacturers must submit a detailed application to the Food and Drug Administration (FDA). The application to the FDA is referred to as ‘510K’ filing. Is there a European equivalent where such information can be found? Unlike in the US, medical devices in the EU do not go through pre-market approval as such. Instead, in order to be placed on the market in the EU, all medical devices must meet the ‘essential requirements’ set out in the relevant MD Directive. Depending on the risk classification of the device, the assessment of whether the essential requirements have been met is carried out by the manufacturer or may involve an independent accredited certification organisation, known as a Notified Body. This is known as the conformity assessment procedure. Following the conformity assessment procedure, the EU Declaration of Conformity is drawn up by the manufacturer and the CE mark affixed to the device. Once the CE mark has been affixed, the device can be circulated freely on the EU/EEA market. For guidance on
What rules apply to postal marketing of third party products to existing customers?
What rules apply to postal marketing of third party products to existing customers? The issues relevant to this scenario are potentially very broad and can be grouped into the following three categories: • processing of the personal data (mainly names and addresses) necessary to send the marketing to recipients • content of marketing material itself • relationship between the advertiser and the product owner or licensor This Q&A addresses the first two categories and does not seek to address contractual or intellectual property issues between the advertiser and the third party, or any other potentially relevant matters. Does the GDPR apply? The General Data Protection Regulation, Regulation (EU) 2016/679 (the GDPR) applies to the processing of personal data. Postal marketing to named individuals from a pre-existing customer database will almost certainly involve the processing of some personal data. The GDPR does not apply to general leaflet drops, circulars, inserts, field marketing, media adverts or other marketing channels which are not individually addressed. If, however, the name of the intended recipient of postal marketing is known, GDPR obligations cannot be avoided by simply addressing the mail to ‘the occupier’, as that individual’s personal data is still being processed behind the scenes. Where the GDPR applies, a lawful ground for processing that data must be identified. Legitimate interests or consent are the most likely lawful grounds, although others may potentially be relevant. Consent The GDPR
How do I deal with database extraction and re-utilisation?
How do I deal with database extraction and re-utilisation? Protection of investment A database right in a database is infringed if an alleged infringer extracts or re-utilises all or a substantial part of its contents or where systematic extraction or re-utilisation of insubstantial part of the contents of the database amounts to the extraction or re-utilisation of a substantial part of those contents. The right to prevent extraction and re-utilisation stems from the database right that protects the investment of the maker of the database in the arrangement and verification of it. This protection of investment is the main point for the client to understand. The protection is not given to the investment in the creation of information but on investment made in the generation of a database as a storage and processing tool for information. 'Substantial investment' is an investment that is considerable in, for example, financial, human or technical resources in a qualitative (intellectual effort or energy) or quantitative sense, or both (see the Directmedia case). Bringing a claim—the risks Database right arises naturally (without a need to register) in a database where there has been substantial investment in obtaining, verifying or presenting its contents. Not all databases are protected by the database right. The only ones that are protected are those in which there has been substantial investment. Discuss with your client that challenging an infringer
What is the EU law on data scraping from websites?
What is the EU law on data scraping from websites? What is scraping? Web scraping is a process by which website data is extracted (ie copied) using a web scraping program. Websites are typically coded in HTML and a range of different web scraping programs have been created which interface with the HTML code to collect copies of the data for use elsewhere. Another type of scraping relevant to website operators is screen scraping. In very basic terms, this involves deploying a program to complete forms on third party websites and then extract the output/results from those forms. Often the program will simulate a human operator to obtain the outputs (which is why websites sometimes set ‘challenge responses’ such as Captcha, requiring the user to enter a code shown on the screen to determine whether that user is a human operator or a program). Some price comparison websites use screen scraping programs. What is the relevant law? Some of the law in this area is derived from, or is, European Law. Although other laws may be relevant, those of primary relevance are: • Copyright • Database right • Data protection • Computer misuse The issues in each of these areas are highlighted below. Copyright Generally speaking, a website will include and be comprised of copyright-protected works. These may include literary works (such as news articles and HTML code) and artistic works (such as photographs and graphic
Can a local authority remove a vehicle which has been left on the highway when the owner is deceased and no next of kin have taken ownership? Should the same procedures be followed but instead of letters addressed to the owner, should they be addressed to the estate?
Can a local authority remove a vehicle which has been left on the highway when the owner is deceased and no next of kin have taken ownership? Should the same procedures be followed but instead of letters addressed to the owner, should they be addressed to the estate? We cannot answer the specific question asked because to do so would require us to give advice which we are not able to do. Much will also depend on the specific circumstances of the case, whether the identity of any next of kin is known to the highway authority and whether they have been asked informally to remove the vehicle. For the purposes of this answer we have assumed that the highway authority is unaware of the identity of any next of kin and has no means of ascertaining who the executors/administrators of the estate are or who may be able to remove the vehicle without use of statutory powers. In these circumstances, the vehicle may well be considered to have been abandoned. Section 3 of Refuse Disposal (Amenity) Act 1978 (RD(A)A 1978) imposes a duty on a local authority to remove abandoned vehicles. However, this duty does not apply where the cost of removing a vehicle to the nearest convenient carriageway is unreasonably high. Where the vehicle is on occupied land, the authority must first
Do you have a service that tracks, analyses and compares public company transactions?
Do you have a service that tracks, analyses and compares public company transactions? Market Tracker is a corporate transaction analysis product that sits within Lexis®PSL Corporate. At its heart is a deal analysis tool which allows users to locate, analyse and compare data in relation to key aspects of public company corporate transactions. In addition, the product offers: • detailed, searchable summaries of the latest public company transactions, containing narrative and key data points extracted by our
Is there any guidance on valuing a clinical negligence claim involving a retained staple/suture which delayed wound healing by a period of seven weeks?
Is there any guidance on valuing a clinical negligence claim involving a retained staple/suture which delayed wound healing by a period of seven weeks? Guidelines for the assessment of damages The Judicial College Guidelines for the assessment of general damages in personal injury refers to damages for minor injuries in chapter 13 (select the table of contents to expand). The guidelines note that minor injuries are injuries which are of short duration, where there is complete recovery within three months and are not otherwise referred to in other chapters. Cases where there is significant pain or multiple injuries
What are IP rights?
What are IP rights? Basic concept Most people are familiar enough with the idea that owning tangible property, such as a car or some land, carries with it some rights, such as not to have it stolen or damaged. So that people are incentivised to create things or new ways of doing something, the law provides rights to creators. These rights are to property, generated by someone's creativity, and they are similar to rights in property such as land—they can be sold, rented out or even mortgaged, and they cannot be trespassed on without the owner's consent. The owner has a right to keep other people away from exploiting this intellectual property (IP), for example stopping them selling the products containing the ideas protected by the IP. There are limits to that right to keep people away, because the intention is that the owner's exclusive rights should not extend so far that competition and free markets are stifled. Creative output could be viewed as a spectrum of activities, with a single line on a piece of paper being an example at one end, and the invention of a complex new life-saving pharmaceutical compound at the other end; there is a great deal of output in between. The law protects different types of creativity in different ways. An introduction to those types of legal protection is provided here. The different
How does YouTube handle infringing content, and what options are open to rights holders? If a false complaint is received by a content creator, what is the process for appealing it and what are the time frames involved in disputing the claim?
How does YouTube handle infringing content, and what options are open to rights holders? If a false complaint is received by a content creator, what is the process for appealing it and what are the time frames involved in disputing the claim? How does YouTube handle infringing content, and what options are open to rights holders? Broadly speaking, YouTube will remove content from its platform for one of three reasons: • a breach of YouTube community guidelines or terms of use • as a result of an automated Content ID claim, or • because it has received a formal copyright notice-and-takedown (sometimes referred to as a Digital Millennium Copyright Act (DMCA) notice because the procedure is largely modelled around ‘safe harbour’ principles contained in American copyright legislation, the Digital Millennium Copyright Right Act 1998) Therefore, in terms of copyright claims, there are two ways in which a claim of infringement can be made. It is important to understand how and why a copyright claim is being made because the process that ensues in dealing with that claim, including the time frames and consequences involved, vary. Content ID claims This system was developed to help all users, from independent creators to larger media corporations, to manage and monitor their content on YouTube with the view to limiting the prevalence of piracy on the platform. Content ID is an algorithm-driven system that scans content uploaded
What are the key features of a Brexit SI?
What are the key features of a Brexit SI? As part of the UK’s domestic preparation for Brexit, the government is introducing a range of primary and secondary legislation, including a significant volume of Brexit-related statutory instruments (Brexit SIs). Both primary and secondary legislation is required for various purposes in connection with Brexit, eg to: • amend provisions of EU-derived UK legislation and direct EU legislation the UK plans to preserve in domestic law after Brexit (retained EU law), which requires correction in anticipation of Brexit (so that it can operate effectively as part of UK law after Brexit) • implement new and revised domestic policy required as a result of Brexit (eg in areas such as immigration, tax, trade, nuclear and environmental policy), and also • reflect provisions of any Brexit-related international agreements enacted in UK law (including the Withdrawal Agreement) Brexit SIs made under the European Union (Withdrawal) Act 2018 The government is using its legislative powers under the European Union (Withdrawal) Act 2018 (EU(W)A 2018), and other primary legislation, to introduce hundreds of Brexit SIs across a wide range of policy areas in advance of exit day. The powers delegated under EU(W)A 2018 can be used to introduce Brexit SIs in advance of exit day for various purposes, including to correct legal ‘deficiencies’ expected to
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Brexit SI Bulletin—latest drafts and sifting committee reports, 24 June 2022
Public Law analysis: The Commons European Statutory Instruments Committee (ESIC) and the Lords Secondary Legislation Scrutiny Committee (SLSC) are responsible for the sifting processes under the European Union (Withdrawal) Act 2018 (EU(W)A 2018) and the European Union (Future Relationship) Act 2020 (EU(FR)A 2020). These committees scrutinise proposed negative Brexit SIs (including SIs concerning the implementation of Brexit and the ongoing UK/EU relationship) and make recommendations on the appropriate parliamentary procedure before the instruments are laid in Parliament. The SLSC is also responsible for considering published draft instruments subject to the enhanced scrutiny procedure under the EU(W)A 2018. This bulletin outlines the latest updates and recommendations, collated on 24 June 2022.
Brexit highlights—24 June 2022
These Brexit highlights bring you a summary of the latest Brexit news and legislation updates from across a range of LexisNexis® practice areas.
Information Law weekly highlights—23 June 2022
This week’s edition of Information Law weekly highlights includes that the UK government has announced details of data protection and privacy reforms. It also includes news that the Department for Digital, Culture, Media & Sport (DCMS) has responded to the consultation on embedding standards and pathways across the cyber profession by 2025 and of other recent developments relating to data protection, cybersecurity, databases and reputation management.
EU Law weekly highlights—23 June 2022
This week's edition of EU Law weekly highlights includes the Commission’s endorsement of candidate status for Ukraine, Georgia, and Moldova, the Commission’s adoption of a proposed regulation mandating the restoration of nature, the Council of the EU’s adoption of a general approach for reform of the Schengen Borders Code, the publication of a strengthened Code of Practice on Disinformation, and provisional political agreement on the EU Corporate Sustainability Reporting Directive. The highlights further include EU Member States formally notifying the first hydrogen IPCEI, adoption of a recommendation on the fair transition to climate neutrality, the publication of the final compromise text on AIFMD II, the Council of the EU agreeing its position on EU Solvency II, and the adoption of the Digital Services Act text in anticipation of a vote in the July plenary session.
Public Law weekly highlights—23 June 2022
This week's edition of Public Law weekly highlights includes the latest updates on the conflict in Ukraine and the sanctions against the Russian state. Also included are selected Brexit headlines, including analysis of the Northern Ireland Protocol Bill, details of the reform on data protection and product conformity markings, updates on the tenth meeting of the Specialised Committee on Citizens’ Rights, progress in the UK's international trade priorities, as well as the latest post-Brexit guidance and SIs. Coronavirus (COVID-19) and Monkeypox updates include the government's response to the joint parliamentary report on lessons learnt, plus key SIs and operational guidance from the courts. Also in this edition, details and commentary on the introduction of the Bill of Rights, responses to the Women and Equalities Committee's report on gender sensitivity in Parliament, the Government Commercial Function's summary guide to the Public Procurement Bill, a consultation on CE-Filing in the Upper Tribunal Lands Chamber, plus additional updates on constitutional and administrative law, judicial review, equality and human rights, state security and intelligence, public procurement, Subsidy control and State aid, information law, and projects and infrastructure. Case analysis this week includes analysis of the Upper-Tier Tribunal (UTT) for Special Educational Needs and Disability (SEND) confirmation that there is a distinction between matters brought under the Children and Families Act 2014 (CFA 2014) and the Equality Act 2010 (EqA 2010).
IP weekly highlights—23 June 2022
Welcome to this week’s edition of the IP weekly highlights: a hand-picked summary of news analysis, updates and new content from the world of IP. These highlights focus on the key rights of copyright and associated rights, database rights, trade marks and passing off, designs, and patents as well as covering issues relating to confidential information, know-how R&D and IP disputes all mainly from a UK and European perspective.
Online Safety Bill—are you caught?
TMT analysis: Louise Popple, Senior Lawyer at Taylor Wessing, discusses what providers of online content and services will need to do to determine whether they are in scope of the Online Safety Bill (the Bill).
TPR urges pensions industry to improve scam reporting
Law360: The Pensions Regulator (TPR) has urged professionals in the pensions sector to follow the example of the banking industry and improve their reporting of suspected fraud.
Public Law weekly highlights—16 June 2022
This week's edition of Public Law weekly highlights includes the latest updates on the conflict in Ukraine and the sanctions against the Russian state, including the government's response to a report on the impact of the measures taken and guidance for trading with Russia. Also included are selected Brexit headlines, including details and analysis of the introduction of the Northern Ireland Protocol Bill followed by the EU's launch of infringement proceedings against the UK, inquiries into the post-Brexit regulatory regime and the Gibraltar border negotiations, progress in the UK's international trade priorities, as well as the latest post-Brexit guidance and SIs. Also in this edition, the ECtHR's granting of an urgent interim measure in the UK-Rwanda removal case, the EHRC's findings of its inquiry into the treatment of low paid ethnic minority workers during the pandemic, and a consultation on legislative changes to implement rail reform, plus additional updates on constitutional and administrative law, judicial review, equality and human rights, Subsidy control and State aid, and management and strategic planning. Case analysis this week includes the latest judicial review, equality and human rights, and state security and intelligence cases, including the High Court's decision on police pensions, human rights and judicial review, the Supreme Court's decision allowing an appeal over care orders after the judge adopted a flawed process when processing options to mitigate risk, and the Investigatory Powers Tribunal's decision clarifying and refining its jurisdiction over complaints about covert surveillance methods and related breaches of the Human Rights Act 1998.
IP weekly highlights—16 June 2022
Welcome to this week’s edition of the IP weekly highlights: a hand-picked summary of news analysis, updates and new content from the world of IP. These highlights focus on the key rights of copyright and associated rights, database rights, trade marks and passing off, designs, and patents as well as covering issues relating to confidential information, know-how R&D and IP disputes all mainly from a UK and European perspective.
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