Health Canada has released its "Overview of the format and content for post-market drug benefit-risk assessment in Canada – guidance document". The objective of the guidance document is to assist market authorisation holders in developing a post-market benefit-risk assessment for a marketed drug when requested.
Two Delaware appraisal decisions issued in 2018 illustrate that, following the Delaware Supreme Court's decisions in Dell and DFC, the Delaware courts remain willing to give substantial evidentiary weight to the deal price as an indicator of fair value where the underlying transaction was the product of an open process characterised by the objective indicia of reliability.
The final form of Brexit remains uncertain, as does its impact on European works councils governed by UK law. As such, employers with European works councils currently governed by the United Kingdom's European works council legislation are strongly advised to conditionally appoint a new representative agent in a state that will remain in the European Union.
A trade union recently filed a claim with the Castile and Leon High Court on behalf of 6,000 in-home carers, asking the court to declare that the time which the carers spent travelling between their home and their first and last clients of the day must be deemed working time in accordance with the applicable collective bargaining agreement. This is a controversial matter on which the Spanish labour courts have reached various conclusions.
A recent Utrecht District Court decision sends a strong reminder to parties in the transport and logistics industry that they must be precise and clear about what they are agreeing to in dealings with their trading partners. While the less formal requirements for concluding an agreement under Dutch law seem to benefit the transport industry, this decision shows that there are pitfalls to be considered.
Under Japanese law, employers must – in principle – pay an allowance to employees who work more than eight hours per day or 40 hours per week. As such, from an employer's perspective, it is practical to include an employee's overtime allowance in their base salary where possible. However, for an employee's overtime allowance to be validly included in their base salary, certain requirements must be satisfied. These requirements are a hot topic in Japanese legal practice.
In a recent case, the jail terms imposed on two directors following a workplace fatality were overturned on appeal and the C$250,000 fine imposed on the company was also reduced. While the results were good for the accused, the Court of Appeal's troubling comments will inevitably be used by prosecutors across Canada in an effort to obtain jail terms as appropriate sentences against directors.
Further to Health Canada's Action Plan on Medical Devices, Health Canada has released, among others, a notice announcing an upcoming meeting of Health Canada's Scientific Advisory Committee on Medical Devices used in the Cardiovascular System and draft guidance to better define regulatory compliance requirements for emerging technologies.
The Bahamian government continues to make progress towards enhancing its aircraft registry and ratifying the Cape Town Convention. For example, the Aviation Steering Committee (ASC) recently presented draft legislation to implement the Cape Town Convention to the attorney general's office. The ASC expects this draft legislation to be approved and presented to the cabinet before the next government budget communication in Summer 2019.
In May 2018 the Aviation Working Group announced plans for a global aircraft trading system (GATS) to modernise the selling, buying and financing of leased aircraft and engines by making such transactions simpler and faster. The GATS will be fully electronic and use e-signatures, e-delivery of documents and a secure e-ledger to record transactions. As such, it is expected to reduce the time and costs required to change German aircraft registrations through the national aviation authority.
Businesses with experience litigating in Ireland will be familiar with the discovery process and the onerous obligation to disclose all relevant documents which are in their power, possession or procurement. In an age when the volume of electronically stored information continues to increase exponentially, the costs and time involved in complying with discovery orders can often be disproportionate; however, change may be on the horizon.
Large corporates based in Ireland typically have a suite of non-life insurance policies to cover a variety of risks. Given the fact that the UK insurance market is the biggest in the European Union, it is likely that at least some of the policies held by corporates based in Ireland will have been written by UK or Gibraltar-licensed insurers. As such, whatever form Brexit ultimately takes, Irish policyholders with policies written by UK insurers must assess any risk to (among other things) their ability to renew.
A recent case before the Court of Appeal provides clear guidance that a defendant may properly plead that it is unable to admit or deny an allegation in circumstances where the allegation's truthfulness or falsity is neither within the defendant's factual knowledge nor capable of being determined from documents or other information available to it.
The Tel Aviv District Court recently acknowledged jurisdiction over a claim filed by an Israeli insurer against a foreign reinsurer that had refused to participate in a settlement agreed by all of the other reinsurers. The court noted that there was no dispute that the reinsurers' agreement included an exclusive jurisdiction clause referring to the Israeli courts and ordered a statement of claim to be served on the reinsurer.
Until 2018, Austria had up to five different cancellation rights for insurance policyholders, plus the cancellation right pursuant to Section 8 of the Distance Financial Services Act. Thus, the legal situation was confusing. However, this has finally changed. Since 1 January 2019, a new Section 5c of the Insurance Contract Act provides for one unified cancellation right.
In a relatively close-knit community such as Hong Kong, it is not uncommon for parties to proceedings or their witnesses, lawyers or experts to be known to a judge or tribunal member, which could create a perception of potential bias. In these circumstances, applications might be made for the recusal of the judge or tribunal member and for the case to be reassigned. Two recent cases serve as a timely reminder of the inherent difficulties and sensitivities involved in an assessment of apparent bias.
Parties that failed to comply with an interim injunction or that violated an injunction previously faced one to six months' imprisonment. However, the Constitutional Court recently annulled this provision due to its lack of clear regulation and legal remedies. The changes will enter into force nine months after their publication in the Official Gazette and are final and binding on legislative, executive and judicial bodies, administrative authorities and real and legal entities.
Switzerland has no specific securitisation legislation. Therefore, securitisation transactions are subject to the general legal framework that applies to all other financial transactions with respect to, among others, both corporate law and regulatory matters. This article provides a short overview of certain company-related aspects to consider when setting up a special purpose vehicle structure for a securitisation transaction in Switzerland.
The Supreme Court of Canada recently reiterated the fact that franchise agreements are relational contracts and are therefore subject to a heightened duty of good faith pursuant to Quebec civil law. This decision is in line with a series of recent Quebec civil law decisions that have broadly interpreted, and arguably extended, the duty of good faith owed by a franchisor to its franchisees.
The Federal Supreme Court recently considered – for the first time – whether board members' rights to information, inspection and insight can also be asserted on an appeal basis. The court also commented on the type of procedure applicable in such cases. This decision should be taken into account by board members who lack evidence or knowledge of important or necessary information, particularly if it relates to the organisation of or disputed relationships within the board of directors.