The de novo medical device process is a little-used but potentially valuable means of securing approval for your medical device. The pathway was established in 1997 subject to the Federal Food Drug & Cosmetic Act, Section 513 (f) (2). It was designed to employ a risk-based strategy for novel devices that have not yet been classified. Basically, it establishes a new device type including classification, regulation, appropriate controls and product code ...
Counterfeiting continues to make the news. Locally, we’ve just had a report of a R10 million bust in the Vereeniging area, during which fake soaps, shampoos, clothing and bags were seized, and seven suspects from Malawi, Mozambique and China (no surprises there), were taken into custody.But we are increasingly getting reports of counterfeiting in product areas that go way beyond the traditional stomping ground of FMCG and luxury goods ...
Is your business affected by counterfeiting? If so, you are not alone. A newly released study shows that almost all intellectual property dependent companies listed on the NASDAQ OMX Stockholm 30 Index have been affected. Moreover, most expect that the problem will continue to grow. Better political support is required to stem this development, but companies already have several weapons available to use against the counterfeiters ...
False labeling of products, fake or inferior materials and components used to make products, and the misappropriated use of another’s trademark are examples of how counterfeit goods and the theft of intellectual property are hurting consumers and companies. The world markets and global supply distribution chains provide opportunities for companies to grow and prosper. Sales through the Internet allow for products to be sold and sent to almost anywhere in the world ...
Upon reconsideration in Gerard v. Orange Coast Memorial Medical Center, Case No. G048039 (March 21, 2017) (Gerard II), the Fourth Appellate District decided that IWC Wage Order 5 is valid and that healthcare employees may waive one of their two required meal periods on shifts longer than 8 hours ...
In the recent case of Hwang Joon Sang & Anor v. Golden Electronics Inc. & Ors (HCA 1529/2019; [2020] HKCFI 1084), Hong Kong’s Court of First Instance allowed a novel mode of ordinary service of court documents, using an online data room, to which the persons so served were given access by being sent a previously Court-approved letter providing a link to the data room with clear pictorial instructions, and by separate communication an access code to the data room ...
On 7 August 2019 the Federal Administrative Court annulled a Federal Office of Public Health (FOPH) order that had limited the price increase of a medicinal product on the list of specialities to two years. The product manufacturer had requested a price increase under Article 67(2) of the Healthcare Insurance Ordinance (SR 832.102), having incurred higher costs following the loss of two suppliers ...
Many environmental impact reports and negative declarations will breeze through analyses of a development project’s impacts on cultural resources ...
The court has considered the discretionary grounds of opposition under the Landlord and Tenant Act 1954 (“the 1954 Act”) in the recent case of Gill v Lees News Ltd [2023] EWCA Civ 1178. In the case, the landlord - Mr Gill - served counter notices in response to section 26 requests for renewal tenancies pursuant to the 1954 Act served by the tenant, Lees News Ltd ...
In X v Jemmy Chien, HCCT 31/2019 the Plaintiff applied to set aside an arbitration award on the ground that there was no valid arbitration agreement between the Plaintiff and Defendant. The Plaintiff’s case was that the Defendant was not the true party to the Service Agreement containing the arbitration agreement, as he had signed it as agent for another (Chen) who was the principal and true party to the Service Agreement ...
In the recent case of Cheng Pan & Anor v Yau Lai Wah, HCA 376/2015, the Court held the Defendant liable for loss and damage caused by water leakage from his property into a neighbouring property, which resulted from the Defendant’s contractors carrying out works to pipes located in the Defendant’s property ...
In a scenario that has played out across the country for nearly a year now, a group of restaurants based in Ohio were ordered by government authorities to close their on-site dining operations to abate the spread of the coronavirus. However, when the restaurants sought insurance coverage for their loss of business income, their insurer, Zurich American Insurance Company, denied coverage. Last week, the U.S ...
The recent case of Bond Tak (Holdings) Ltd v King Fame Trading Ltd, HCA 2129/2018, concerned an application by the Defendant to dismiss or permanently stay the High Court action on the grounds that the dispute was subject to an arbitration agreement and should be submitted to arbitration or, alternatively, the action should be stayed on the grounds of forum non conveniens and in favour of the Intermediate People’s Court of Guangzhou City in Mainland China (Guangzhou Court) ...
In the recent case of Redland Precast Concrete Products (China) Ltd v Permasteelisa Hong Kong Ltd, HCCT 35/2018, the Court had to decide whether a contract existed between the Plaintiff and Defendant whereby the Defendant agreed to appoint the Plaintiff as its subcontractor for works to be carried out on a project ...
In the recent case, Wong Wai Yin v Buildings Department, HCAL 1722/2020, the Court dismissed the Applicant’s application for leave to apply for judicial review against a decision made by the Director of Buildings (Director) of the Buildings Department (BD) to prosecute her for failing to comply with an order to demolish unauthorized building works (UBW) ...
Bank Accounts were reinstated after Bank failed to give justified reasons for termination under AML/CFT obligations. 1. Facts of the Case APS Bank p.l.c ...
Key Points Public agencies must retain emails that would be required for inclusion in an administrative record pursuant to CEQA. Agencies must retain “[a]ll written evidence or correspondence submitted to, or transferred from” them “with respect to” CEQA compliance or “with respect to the project.” This includes emails that fit this description ...
(Antelope Valley Groundwater Cases, JCCP No. 4408 (3/16/21))[1] After twenty-two years, the protracted proceedings in the Antelope Valley groundwater adjudication resulted in a settlement and court-approved "physical solution." A physical solution equitably allocates available water under California's laws governing water rights. The physical solution in Antelope Valley limited pumping to balance the overdrafted aquifer with the available native safe yield ...
The Court of Appeal has overturned a decision by the Upper Tribunal and confirmed that a property guardianship scheme did not mitigate liability for business rates. Background Property guardians are individuals who temporarily live in empty property at reduced rents, ostensibly to protect it from damage and squatters. Typically, they are students, key workers or young professionals looking for cheap living space ...
Key Points The California Court of Appeal has issued the first published opinion interpreting California Senate Bill 35's (SB 35) new laws that streamline the approval of much-needed housing projects. Under SB 35, qualifying housing projects are eligible for ministerial review, which can reduce entitlement processing times by months if not years. In Ruegg & Ellsworth v. City of Berkeley (Cal. Ct. App., April 20, 2021, No ...
The Court of Appeal (CoA) has allowed a SIPP investor’s appeal in Adams v Options UK Personal Pensions LLP (2021) EWCA Civ 474 and provided important guidance on the interpretation of Article 25 and 53 of the Financial Services and Markets Act 2000 Regulated Activities Order 2001 ...
There were conflicting judicial opinions of first instance courts as to whether the exception in summary judgment applications under Order 14, rule 1(2)(b) of the Rules of the High Court (Cap. 4A) (Fraud Exception) covers actions in which the defendant is not alleged to be a party to the fraud, but where allegations of fraud are made against a third party. In R. Stahl Inc ...
In the Industrial Tribunal case of David Magro v HSBC Bank Malta plc, the applicant alleged that he had been unfairly dismissed when the defendant bank had not accepted to renew his career break, resulting in his employment being terminated. The applicant had been granted such a renewal for several years but had agreed with the Bank that the last renewal would be final, and that by a specific date, he had to either resign or return to perform his duties with the Bank ...
Under section 327 of the Companies (Winding Up and Miscellaneous Provisions) Ordinance (Cap. 32), the Court can exercise its discretion to wind up a foreign-incorporated company. A recent case reaffirms the three core requirements necessary to enable the court to exercise that discretion ...