On May 28, 2013, the US Food and Drug Administration (FDA) published a draft guidance entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements."1 The draft guidance describes FDA’s views on defining, establishing and documenting the responsibilities of parties that are involved in the contract manufacturing of drugs that are subject to current good manufacturing practice (cGMP) requirements ...
After the Netherlands, Slovakia, and the UK, it is now France’s turn to impose Sunshine-like obligations on the pharmaceutical industry. Soon, similar obligations will apply to all EU countries, after EFPIA, the European trade association for the pharmaceutical industry, adopts a code of conduct on disclosure of transfers of value between pharmaceutical companies and health care professionals or institutions ...
On May 1, 2013, Spilman Thomas & Battle, PLLC, in conjunction with the North Carolina Bankers Association, held The Future of Community Banking Symposium in Greensboro, N.C. It was a day-long discussion of the issues facing and opportunities for community banking. Our day was highlighted by a keynote address from Congresswoman Shelley Moore Capito (R-W.Va.), who chairs the House Subcommittee on Financial Institutions and Consumer Credit ...
This is the first in a recurring series of articles examining the Dodd-Frank Act and its implications for community banks. This quarter’s selection takes a closer look at reforms related to corporate governance issues.In addition to extensive provisions affecting large and small institutions, the Dodd-Frank Act set forth certain corporate governance reforms all businesses, including community banks, need to keep in mind ...
On March 28, 2013, the Commodity Futures Trading Commission (“CFTC”) issued a final order exempting specified transactions by certain regional transmission organizations (“RTO”) and independent system operators (“ISO”) from all but the general anti-fraud and anti-manipulation prohibitions of the Commodity Exchange Act (“CEA”) and related CFTC regulations promulgated thereunder (“Exemptive Order”).1 This alert outlines the Exemptive Order ...
Last week, a federal jury in South Carolina found that Tuomey Healthcare System, Inc. violated the Stark Law and the False Claims Act by submitting false claims for reimbursement to the United States, resulting in $39 million in damages to the government. United States ex rel. Drakeford v. Tuomey Healthcare Sys., Inc., No. 3:05-2858-MBS (D.S.C. May 8, 2013) ...
On April 1, 2013, the U.S. Commodity Futures Trading Commission (“CFTC”) issued a final rule exempting swaps between certain affiliated entities from the clearing requirement under section 2(h)(1)(A) of the Commodity Exchange Act (“CEA”) and CFTC regulations (“Final Rule”).1 This alert outlines the rule and raises some questions as to its conditions and impact. I ...
The hacker group Anonymous announced that it, in concert with Middle East- and North Africa-based criminal hackers and cyber actors, will conduct a coordinated online attack labeled "OpUSA" against banking and government websites today, May 7. Anonymous stated that OpUSA will be a distributed denial of service (DDoS) in which websites may be defaced and legitimate users may be unable to access websites ...
Chapter 43 Philippines Rafael A Morales1 I INTRODUCTION Banks in the Philippines are classified into (1) universal banks, (2) commercial banks, (3) thrift banks, (4) rural banks, (5) cooperative banks, (6) Islamic banks, (7) government-owned banks, and (8) other banks as may be classified by the Bangko Sentral ng Pilipinas (‘BSP’) ...
Regulatory framework- 1 What are the principal governmental and regulatory policies that govern the banking sector? The government recognises the vital role of banks in providing an environment conducive to the sustained development of the country’s economy ...
Traditionally the Spanish business sector has financed its growth primarily through bank loans. However, the current restrictions on credit (derived not only from the crisis but of growing capital constraints of banks themselves) have to seek funding alternative or complementary to the bank ...
On February 1, 2013, the Supreme Court overturned a controversial decision of the Ontario Court of Appeal which granted pension beneficiaries priority over dip lenders in the context of a restructuring under the Companies' Creditors Arrangement Act ("CCAA")1. The Court of Appeal's decision led many to worry that lenders would be reticent to advance funds to restructuring debtors for fear of not being able to secure charges which would outrank all other claims ...
On April 17, 2013, the Health and Human Services Office of Inspector General (OIG) released an Updated Provider Self-Disclosure Protocol (SDP), which replaces the original SDP published in 1998. The SDP is used by providers and suppliers to voluntarily disclose violations of the fraud and abuse laws. According to the OIG, it has received more than 800 disclosures since the SDP’s inception, resulting in more than $280 million in recoveries ...
The decision of the Indian Supreme Court to deny Novartis’s application for patent protection for an improved version of its patented Glivec drug – the culmination of a seven-year battle - has certainly made the headlines. There are a number of reasons for this. First, Glivec is a well-known drug – described by some as a ‘wonder drug’ – that’s used to combat cancer, including leukaemia and gastro-intestinal cancer ...
Recently, the Superior Court rendered a decision 1 which clarifies the extent of the discretion a court has when asked to ratify a hypothecary creditor's recommendation to appoint an employee of its legal counsel to act as the officer of the court entrusted with the sale by judiciary authority of the collateral secured in its favour. CONTEXT The Superior Court had to render judgment in five cases involving very similar facts ...
On March 26, 2013, the Office of the Superintendent of Financial Institutions (“OSFI”), the Canadian bank regulator, issued an Advisory in which it identified the banks considered to be systematically important for Canada in accordance with the framework set out by the Basel Committee on Banking Supervision. These banks are the Bank of Montreal, the Bank of Nova Scotia, the Canadian Imperial Bank of Commerce, the National Bank of Canada, the Royal Bank of Canada and the Toronto-Dominion Bank ...
The Commodities Futures Trading Commission (the “CFTC”), pursuant to its rulemaking authority under the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank”)1, has interpreted guarantees of swap agreements to fall under the definition of a swap,2 which means that any swap guarantor must be an “eligible contract participant” (“ECP”) at the time a swap is entered into (which may occur after the date on which the guarantee and related credit facility documents are entered
Canadian ratification of the Convention on International Interests in Mobile Equipment and of the Protocol to the Convention on International Interests in Mobile Equipment on Matters Specific to Aircraft Equipment: This Bulletin is intended as a brief overview of the above-mentioned Convention and its Protocol and is not an in depth analysis of each of their provisions ...
According to December 2012 data from the federal Bureau of Labor Statistics, the unemployment rate for Gulf War Era veterans, hovering around eight percent, remains higher than the national rate. Over the last decade, more than 2.3 million Americans were deployed to military duty in Iraq, Afghanistan or both. Of that total, more than 1 million have since left the military ...
Many banks formed holding companies in the late 1980s and 1990s. They had various reasons for doing this. Some formed a holding company to hold subsidiaries providing nonbank activities. Some used the holding company to reduce state taxes in states where banks are taxed differently. Some were acquisitive, and holding companies gave them more options in acquiring banks. Some thought the holding company would help improve the marketability of the stock ...
For the first time ever, North Carolina’s Business Court and Court of Appeals both upheld fiduciary duty claims against banks in late 2012. Debtors frequently employ such claims in an attempt to shift liability for failed projects to their lenders or to pressure lenders to settle problem loans in the wake of the financial downturn. Despite their ubiquity, breach of fiduciary duty claims had proven elusive for borrowers before October 2012 ...
It appears that the industry is starting to “enjoy” a modest increase in activity as to participations, assignments and syndications. This “enjoyment” is not without more than a fair share of trepidation and reluctance, but the allure of increased revenue is difficult to withstand. Regardless of this trepidation, participations, assignments, syndications and intercreditor agreements can be done safely and profitably ...
A federal court jury in Illinois found that nursing home operator Momence Meadows fraudulently billed Medicare and Medicaid for “worthless services” and falsely certified compliance with health care laws and regulations, resulting in $28 million in damages to the government. United States ex rel. Absher v. Momence Meadows Nursing Ctr., Inc., No. 2:04-cv-02289 (C.D. Ill. Feb. 8, 2013) ...
