Denmark has a large life science sector, including a number of biotech and pharmaceutical companies and research activities. The sector is highly regulated and covered by extensive and complicated statutory requirements, executive orders and ethical standards. Denmark has incorporated most of the EU regulation and Danish law is thus to a large extent in conformity with the general EU regulation and practice of, for example, the European Medicines Agency (‘EMA’) ...
The White House recently issued a report outlining potential incentives that may be available to companies that adopt the voluntary cybersecurity framework currently being developed by the National Institute of Standards and Technology (the “Framework”). Both the incentives program and the Framework are being developed pursuant to the February executive order aimed at improving the cybersecurity of America’s critical infrastructure (read our prior coverage of the executive order here) ...
On August 12, 2013, the United States Court of Appeals for the Fifth Circuit in Joe W. and Dorothy Dorsett Brown Foundation, et. al. v. Frazier Healthcare V, L.P., et al. affirmed the decision of the United States District Court for the Western District of Texas dismissing with prejudice all claims stemming from the 2011 acquisition of Ascension Orthopedics, Inc. (“Ascension”) by Integra LifeSciences (“Integra”) ...
Never has there been a more controversial law in the past decade than the Reproductive Health Law (“RH Law”). After a long and contentious battle in Congress, the law was finally passed. But the fervent opposition by the so-called Pro-life groups (chief among them the Catholic Church) endures. Four days after the approval of the law’s Implementing Rules and Regulations (“IRR”), the Supreme Court on March 19, 2013, halted its implementation, issuing a 120-day status quo ante order ...
TCI’s anti-money laundering (AML) regulations were extended in 2010 to certain classes of non-regulated financial business (NRFBs). The categories concerned include:- A person who by way of business provides accountancy or audit services.A person who by way of business acts as a real estate agent.An independent legal professional ...
On August 13, 2013, significant amendments to National Instrument 41-101 - General prospectus requirements, National Instrument 44-101 - Short form prospectus distributions, National Instrument 44-102 – Shelf distributions and National Instrument 44-103 – Post-receipt pricing (and their respective companion policies) regarding permissible “pre-marketing” and “marketing” activities came into force (collectively, the “New Amendments”) ...
INTRODUCTION On July 17, 2013, the Court of Appeal issued an unprecedented judgment in Quebec in the case of Theratechnologies inc. v. 121851 Canada inc.1 Justice Clément Gascon, writing for the court, held, in a unanimous decision, that a judgment having authorized a class action for damages under section 225.4 of the Securities Act (Quebec)2 (hereinafter the “S.A.”) can be appealed despite the rule laid down in the Code of Civil Procedure (Quebec) (hereinafter the “C.C.P ...
On 13 June 2013, the Supreme Court of the United States handed down its unanimous decision in the ongoing case of Association for Molecular Pathology et al v Myriad Genetics, Inc. et al 12-398, 569 US __ (2013). This case is the first brought in the US directly challenging the patentability of human genes and for that reason is extremely important to any entity involved in the biotechnology industry which relies on human genetics research as part of innovation strategy ...
On January 17, 2013, the United States Bankruptcy Appellate Panel for the First Circuit (the "First Circuit BAP") rendered its opinion in Massachusetts Department of Unemployment Assistance v. OPK Biotech, LLC (In re PBBPC, Inc.), BAP No. MB 12-042 (B.A.P. 1st Cir. Jan ...
IntroductionOn July 23, 2013, the U.S. District Court for the District of Columbia1 (the “District Court”) upheld Rule 13(p) (the “Rule”) under the Securities and Exchange Act of 1934, as amended (the “Exchange Act”). This Rule imposes investigative and public disclosure requirements on companies that use “conflict minerals” in their manufactured products ...
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 ...
One way to change the law fast is to amend or repeal statutes in budget legislation. That is what the federal government of Canadadid in 2009, 2010 and 2011. Federal programs, staff positions and budgets for environmental science, conservation and protection have been eliminated. That leaves a lot of responsibility with the provinces and territories, and many open questions for industry. This article describes what has happened and identifies what to look out for ...
There is no centralised data available on M&A in the Philippines. However, based on general investment data compiled by investment promotion agencies (such as the Board of Investments (BOI) of the Philippines) and the Bangko Sentral ng Pilipinas (BSP), total approved foreign direct investment (FDI) for 2012 reached 289.1 billion Philippine pesos, which surpassed the previous year’s record level of 258.2 billion Philippine pesos by 12 per cent ...
The ICSA has published new guidance on terms of reference for audit, remuneration, nomination, risk and executive committees, as well as new guidance on matters reserved for the board. The new guidance notes have been revised to reflect the updated editions of the UK Corporate Governance Code (“Code”) and FRC Guidance on Audit Committees published in September 2012 and which apply to all companies with a premium listing with reporting periods beginning on or after 1 October 2012 ...
The ABI has published a report on improving corporate governance and shareholder engagement. The report is a critical evaluation of the roles and responsibilities of the main elements of corporate governance, including: • The role of the non-executive in providing constructive challenge. • How institutional investors hold companies to account. • The relationships between, and responsibilities of, asset managers and asset owners ...
Decree-Law 2/2005 of 27 December, which approved the Mozambican Commercial Code, makes it possible for Mozambican or foreign individuals or clients to set up business in Mozambique in one of six different ways: (i) general partnership (Sociedade em Nome Colectivo); (ii) limited partnership (Sociedade em Comandita); (iii) capital and industry partnership (Sociedade de Capital e Indústria); (iv) quota company (Sociedade por Quotas); (v) single person quota company (Sociedade Unipessoal por Quotas)
On the 19th of July, CMVM Regulation no. 4/2013 on the corporate governance of the issuers of shares admitted to trading in Portugal (“Issuers”), and a new version of the CMVM Corporate Governance Code amending the code in effect since 2010 (“2013 Corporate Governance Code”), were published. Although the aforementioned CMVM Regulation no ...
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 Pensions Regulator has issued revised codes ofpractice and guidance on reporting the late payment of contributions to ensure a system of effective monitoring of contributions in money purchase work-based and personal pension schemes. The revised codes, which are designed to support auto-enrolment, are expected to come into force this autumn ...
Although non-compliance with the Consumer Protection Act (the “CPA”) is generally sanctioned by the nullity of the CPA non-compliant clauses, or of the contract in its entirety, in cases involving written notices of forfeiture of the benefit of the term, the courts have sometimes decided to maintain the validity of the non-compliant notices if they were not prejudicial to the consumer’s rights. The following two judgment support this view ...
In September 2012, we reported that the Supreme Court of British Columbia had rendered a judgment1 confirming that a corporate policy imposing an advance nomination process for a shareholders’ meeting was reasonable and did not infringe the shareholders' rights relating to the election of the corporation's directors (“Advance Notice Policy”) ...
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 ...
