BackgroundFollowing much anticipation on the part of health care industry members, CMS released its long-awaited final rule on the Physician Payment Sunshine Act in February 2013, supplying clarification and guidance on new financial disclosure requirements governing pharmaceutical and medical device manufacturers. The rule includes extensive and potentially time-consuming mandates for drug and device companies, including reporting of annual payments to physicians and teaching hospitals ...
The Financial Services Commission (“FSC”) which was established on April 1, 2011 under the Financial Services Commission Act, 2010-21 (the “Act”) has been mandated to, amongst other things, supervise and regulate the operations of the financial services sector other than the banking services ...
Translation of the FAQ on the New Foreign Exchange Rules:What currency should be used to pay the salaries of employees in angola?The salaries of employees who are foreign exchange residents in Angola, irrespective of the sector of activity, must be paid in Kwanzas, the national currency. When Will i start to receive my salary in KWanzas?As of 1 July 2013, in accordance with the implementation calendar of Law 2/12 of 13 January, defined by Order no ...
Banks are classified into universal banks, commercial banks, thrift banks (composed of savings and mortgage banks, stock savings, loan associations and private development banks), rural banks, cooperative banks, and Islamic banks. The General Banking Law governs primarily universal and commercial banks, as well as cooperative banks ...
In Novozymes A/S v. DuPont Nutrition Biosciences APS, 2012-1433 (Fed. Cir. July 22, 2013), the Federal Circuit affirmed the district court’s grant of DuPont’s post-trial motion for judgment as a matter of law holding that Novozymes’ U.S. Patent No. 7,713,723 (“the ’723 patent”), directed to a variant of alpha-amylase, was invalid under 35 U.S.C. § 112, first paragraph, for failing to satisfy the written description requirement.2 (Slip op. at 18) ...
The insolvency of one or other of the parties to a dispute has become commonplace in recent times, particularly in construction related disputes. Practitioners are becoming increasingly knowledgeable about the implications of insolvency on procedure and the potential remedies available ...
The financial services sector tends to define “high-net-worth individual” (HNWI) asan individual or a family possessing substantial amount of investable funds. There is no generally accepted prefixed denominationof the size of wealth that an individual must possess in order to fall within this category. However, high net worth is commonly used in terms of liquid assets exceeding a certain amount while precise figures differ by financial institution and region ...
2012 was a challenging year for Australia's loan markets. Australian loan markets were affected by continued uncertainty in global markets due to concerns over the Eurozone, the slowdown in China, a weak recovery in the US and, towards the end of the year, concerns around the US "fiscal cliff". Locally, there has been a lack of confidence among corporates, resulting in sluggish M&A activity. Certain sectors of the economy remained relatively soft, such as the retail sector ...
Internal investigations are a central part of the crisis management response, and whilst the form and structure of the investigation will depend on the type of crisis, investigations will generally focus on identifying root causes and those with responsibility for the crisis ...
The FCA’s new webpage, published on 24 July 2013, will record permissions and passports granted under the AIFM Directive. The FCA is currently updating the Financial Service Register to include firms which have been granted new permissions under the Directive, as well as any associated management passports. However, in the meantime, information will be published on the webpage. For more information in respect of the Directive, please visit our AIFMD microsite ...
The Court has now issued its written decision. This provides further analysis and confirms the position that we previously reported. Parties represented The Scottish Environment Protection Agency, Scottish Natural Heritage, East Ayrshire and South Lanarkshire Councils and the Lord Advocate on behalf of the Scottish Ministers were all represented at the hearing ...
Statute of limitations for appeal of public auction contractsThe Higher Commercial Court recently clarified several issues relating to the statute of limitations for appeals of public auction contracts. (Higher Commercial Court of Ukraine Resolution 10 ("On Certain Practical Issues of Statute of Limitation Application"), May 29 2013 ...
Minister of Health Regulation No. 30 of 2013 on The Inclusion of Information on Sugar, Salt, and Fat Content, and Health Impact Messages for Processed and Fast Foods is aimed at lowering the exposure of the public to the risk of non-contagious disease such as hypertension, stroke, diabetes and heart attacks, which can be caused by the excessive consumption of processed or fast foods ...
The Minister of Health has issued Regulation No. 28 of 2013 on Affixing Health Warnings and Information on Tobacco Product Packaging which came into force on 12 April 2013, as a further implementation of Government Regulation No. 109 of 2012 on Control of AddictiveSubstances in the Form of Tobacco Products. The Regulation requires tobacco producers and importers to affix pictorial health warnings and health information on their tobacco products packaging ...
The Head of the National Drug and Food Control Agency (Badan Pengawas Obat dan Makanan – “BPOM”) recently issued Regulation No. 27 of 2013 on The Supervision of Drugs and Food Imports into Indonesian Territory which came into effect on 28 May 2013. This Regulation repeals and replaces the previous regulations on Imports of Processed Foods, Cosmetics and Drugs ...
While arbitration offers an excellent means for parties to get their disputes settled faster than in traditional courts, how you draft the arbitration clause in a document is critically important for a positive outcome – should a dispute arise. Legal agreements often have a clause indicating that parties agree to settle any disputes arising from the arrangement in arbitration. The text for this clause is frequently supplied by a local arbitration institute ...
Don't bank just yet on putting your marketing muscle behind the safe and effective off-label uses of your FDA-approved drugs, or defending your next mass consumer class action on First Amendment grounds. But you can start giving those multi-billion dollar prospects some serious thought, because constitutional winds are blowing through the Code of Federal Regulations ...
On July 2, 2013, the U.S. District Court for the District of Columbia1 (the “District Court”) vacated Rule 13q-1 (the “Rule”) under the Securities and Exchange Act of 1934, as amended (the “Exchange Act”) ...
On July 10, 2013, the United States Securities and Exchange Commission (the “SEC”) adopted amendments to Rule 506 of Regulation D under the Securities Act of 1933, as amended, that will lift the ban on general solicitation for certain private offerings, including offerings of private fund interests (“New Rule 506(c)”). New Rule 506(c) will become effective 60 days after publication in the Federal Register ...
On July 10, 2013, the Securities and Exchange Commission (SEC) adopted the new, much-anticipated rules that lift the ban on general solicitation and advertising in connection with certain private offerings of securities ...
Legal succession of banksUkrainian legislation prescribes a special reorganisation procedure for banks that, among other things, requires banks to:• develop a reorganisation plan;• obtain approval for internal statute changes from the National Bank of Ukraine; and• conduct an audit to ensure the correctness of transfers (for mergers and acquisitions) or the demerger balance sheet (for spin-offs and transfers) ...
Myriad Genetics is known as a leader in the market for diagnostic testing of BRCA1 and BRCA2 gene mutations that have been linked to breast and ovarian cancer. These same diagnostic tests were recently in the celebrity press, as Angelina Jolie announced she had been tested positive for the mutations, resulting in her electing to have a preventative double mastectomy ...
Court decisions regarding company names are rare. So the recent decision of the Western Cape High Court in the case of Bloomberg’s Posterity Investments (Pty) Ltd v The Registrar of Companies and Bloomberg LLP is worth discussing. What makes company name cases interesting from an intellectual property (IP) law point of view is that they deal with issues that are very similar to the issues that are dealt with in trade mark infringement and passing-off cases ...
Governor Perry recently signed four bills into law designed to combat Medicaid fraud, waste, and abuse. The bills are a mixed bag of enhanced enforcement capabilities for the state and a few new protections for healthcare providers. Most notably, the legislature made several changes to the Texas Medicaid Fraud Prevention Act (TMFPA), bringing the statute more in line with the federal False Claims Act. Changes to the Medicaid Fraud Laws On the enforcement side, S.B ...
