On January 4th, 2016, the President of the Republic introduced a series of amendments to the bill of law that, “modifies the Health Code in order to regulate generic bioequivalent pharmaceutical products and prevent the vertical integration of pharmaceutical laboratories and pharmacies”, – Bill No. 9914-11- (“Pharmaceutical Bill II”) ...
Increased deal activity is likely in Australia's health and aged care sector in 2016, driven by:• investment interest from China• Australian players targeting outbound opportunities through joint ventures and partnerships; and• consolidation in the aged and home care services areas.Rapidly ageing populations across our region are driving demand for high quality health care, especially in countries such as China and Japan ...
Are you ready to disclose? All Transfers of Value (ToV) from 2015 must be disclosed publicly via the Irish Pharmaceutical Healthcare Association (IPHA) central reporting system by 1 July 2016. This relates to all ToVs that were made by pharmaceutical companies to Healthcare Providers (HCPs) and Healthcare Organisations (HCOs) in connection with the development and sale of prescription only medicinal products for human use ...
The Second Circuit issued an important decision recently in In re Sanofi Securities Litigation applying the Supreme Court’s landmark Omnicare decision. In Omnicare, the Supreme Court held that a statement of opinion, even if honestly believed, could be actionable if the issuer failed to disclose material facts that conflict with what a reasonable investor would, in context, expect about the issuer’s basis for the opinion ...
The Consumer Financial Protection Bureau (“CFPB”) recently announced a settlement with Dwolla, Inc., an online payment processor, for allegedly deceptive statements Dwolla made to consumers regarding the company’s data security practices. In the settlement, Dwolla agreed to pay a $100,000 penalty and take specific actions to improve its data security ...
Since mid-February, there has been an ongoing debate in the public sphere regarding the high profile case that found the global IT giant Apple and FBI on opposite sides of the legal spectrum. The case's background involves the 2015 San Bernardino shooting incident in USA, and the fact that one of the perpetrators was in possession of an iPhone potentially containing relevant information for the ensuing investigation ...
On 16 February 2016, the Bosnian Competition Council made a ruling in favour of the cable operator and Karanović & Nikolić's client – Telemach – in the case against HD Win, the owner of the sports channel "Arena Sport", and a subsidiary of Telekom Serbia. The authority imposed a fine against HD Win for its abuse of dominant position and ordered it to enter into agreement with Telemach in order to allow its subscribers access to Arena Sport ...
On February 12, 2016, the Securities and Exchange Commission (the “SEC”) issued 18 no-action letters concerning requests to exclude proxy access shareholder proposals from proxy materials pursuant to Rule 14a-8(i)(10) of the Securities Exchange Act of 1934, as amended. Rule 14a-8(i)(10) permits a company to exclude shareholder proposals from its proxy materials if the company has already “substantially implemented” such proposals ...
On February 16, 2016, the recently constituted Philippine Competition Commission (“PCC”), which was created under the Philippine Competition Act (Republic Act 10667 or the “PCA”), issued Memorandum Circular No ...
Karanović & Nikolić is proud to announce the promotion of new Partners and Senior Associates. The following employees have been recognised for their hard work and dedication to our values and goals, and we hope this promotion will only increase their drive and commitment in the future ...
We have news coming from Slovenia, where it has recently been reported that the European Investment Bank (EIB) will be opening its office in the country's capital, Ljubljana, during the summer months. This piece of news does not come as too big of a surprise, since the Slovenian economy has enjoyed EIB's considerable presence over the last couple of years, with its investments during last year alone totaling EUR 798 million ...
The Modern Slavery Act 2015 introduces a new area of compliance for commercial organisations. The Act is amongst the toughest anti-slavery and human trafficking legislation in the world. Although legal penalties are restricted, interest from patients, consumers, investors, NGOs, pressure groups and brand risk is expected to enforce compliance ...
On 16 February 2016, the Bosnian Competition Council made a ruling in favour of the cable operator and Karanović & Nikolić's client – Telemach – in the case against HD Win, the owner of the sports channel "Arena Sport", and a subsidiary of Telekom Serbia. The authority imposed a fine against HD Win for its abuse of dominant position and ordered it to enter into agreement with Telemach in order to allow its subscribers access to Arena Sport ...
Last week, the General Court of the European Union dismissed Coca Cola's request to register its bottle shape without fluting as a Community trade mark, further denying the soft drink giant's intention, five years since the application in question was initially submitted. Back in December, 2011, Coca-Cola filed an application to the Office for Harmonisation in the Internal Market (OHIM) for the registration of its glass bottle without fluting as a Community trademark ...
The legal landscape for doing business in Iran has changed significantly in the past seven months. On July 14, 2015, the P5+1 (the United States, the United Kingdom, Germany, France, China and Russia), the European Union and Iran agreed and signed a Joint Comprehensive Plan of Action (“JCPOA”) contemplating the easing of certain Iran related sanctions ...
In a third and final round of settlements with underwriters, the SEC announced on February 2, 2016 enforcement actions against 14 firms for alleged misstatements and omissions in municipal bond offerings ...
NewLegislation Enables the Public Offering of Foreign Fund Units in Israel for theFirst Time On February 10, 2016, the IsraeliParliamentary Finance Committee approved regulations ("Regulations")which will enable the public offering of foreign mutual fund units inIsrael. The Regulations will take effectwithin six months from the date of publication. Prior to the enactment of theRegulations, the Israeli Joint Investment Trust Law permitted the offering offoreign funds in Israel ...
After a long wait, on February 12, 2016, the Centers for Medicare & Medicaid Services for HHS (“CMS”) issued a final rule that clarified the obligations of Medicare providers and suppliers to report and return overpayments within 60 days (the “Rule”).1 The Rule becomes effective on March 14, 2016. The Rule, which applies only to Medicare Part A and B providers and suppliers, enforces a statutory requirement from 2010 implemented by the Affordable Care Act (“ACA”) ...
The jurisdictional thresholds for premerger notification filings under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (“HSR Act”) will increase February 25, 2016, and will apply to any transaction closing on or after that date. The revised thresholds will remain in effect until the next annual adjustment, expected in the first quarter of 2017.To read the full alert, click here ...
Lavery closely monitors new developments in consumer law and is committed to keeping the business community informed of the latest developments in this area of the law by regularly publishing newsletters dealing with new case law or legislative changes which may impact, influence, or even transform practices in the retail sector ...
Less than two days after an enforcement moratorium expired, U.S. and EU officials in transatlantic data transfer talks have reached a new “Privacy Shield” framework to replace the Safe Harbor regime struck down in the Schrems case last year. The new framework, also known as Safe Harbor 2.0, is expected to increase obligations on U.S. companies that handle the personal data of Europeans, while bringing stronger privacy enforcement by the U.S. Federal Trade Commission (“FTC”) ...
On January 1, 2016 Law No. 20,848 which sets forth a new legal framework for foreign direct investment in Chile (the “New Law”) was enacted. The New Law also regulates the effects of contracts entered into during the term of Decree Law No. 600 of 1974 (“DL 600”), in order to guarantee the full validity of the rights and duties acquired by foreign investors under said legal regime ...
Times are tough, very tough, for many mid-cap and small-cap exploration and production (“E&P”) companies. Crude oil prices have fallen from more than $100/barrel in July 2014 to a twelve-year low of less than $30/barrel in January 2016. Natural gas prices are at a three-year low. The growing consensus is that depressed prices will experience a slow recovery that may continue into the 2020s ...
Over the past year, the Tribunal administratif du Québec (TAQ) has issued several rulings dealing with oversight of the medical practice of professionals working in health and social services institutions. Several of these rulings will be of interest to institutions since they set out principles that tend to confirm the existence of a form of management rights over physicians, despite the lack of the traditional relationship of subordination between such institutions and their physicians ...
To give effect to the constitutional right to privacy, on 20 August 2013, the National Assembly passed the Protection of Personal Information Bill (B9D of 2009), which is largely based on the European Data Protection Directive (to be replaced in due course by the stricter General Data Protection Regulation). The Bill was signed into law by the President on 19 November 2013 and was gazetted as the Protection of Personal Information Act 4 of 2013 (“POPI”) on 26 November 2013 ...
