Sponsors

News & Analysis as of

FDA Issues Warning Letter to Corporate Sponsor of Clinical Trial

The U.S. Food and Drug Administration (FDA) does not frequently issue Warning Letters to corporate sponsors of FDA-regulated clinical trials, so the June 16, 2015, Warning Letter sent to AB Science, a pharmaceutical company...more

Olympic Athletes May Get Chance to Sport Sponsors

Taking office amid widespread criticism surrounding Russian anti-gay legislation and the Sochi Winter Games, International Olympic Committee President Thomas Bach began his leadership in 2013 with reform on his agenda. “It’s...more

Federal Circuit Finds Biosimilar Patent Dispute Resolution Procedures Optional

In Amgen v. Sandoz, a divided panel of the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that appears to favor biosimilar applicants...more

J-1 Training Plan Updates: What Host Companies Should Know

The Department of State issued an updated Form DS-7002, Training/ Internship Placement Plan for the Student and Exchange Visitor Information System (SEVIS), a web-based information system maintained by the Department of...more

Tribute To Eddie LeBaron and CCO as Compliance Project Sponsor

Today we celebrate Eddie LeBaron, who died last week. LeBaron was a diminutive pro quarterback for 11 seasons in the National Football League (NFL) in the 1950s and 1960s. He was also a lawyer and decorated veteran, having...more

How Subcontractors Can Protect Themselves Following Binghamton Simulator

Subcontractors often play important roles in government contracting. A subcontractor may, for example, take the lead in drafting what becomes a winning proposal. A subcontractor may work on a day-to-day basis with...more

Sweepstakes random drawings: Things a sponsor should know

I am often asked how random drawings should be conducted to select the winners of a sweepstakes. It sounds like a fairly simple request, but like most legal questions, “it depends.” For random drawings, it depends on the type...more

Switcheroo

Long suffering Vikings fans–a population of which I am a proud/depressed member–received emotionally confusing news earlier this week. Adrian Peterson, scourge of the NFL, pled out of his felony child abuse case for a lesser...more

Surge in FOIA Requests to State Agencies Seeking Information About PE and Other Alternative Investment Fund Sponsors

We have recently observed a surge in freedom-of-information (“FOIA”) requests made by media outlets to state pension funds and other state-government-affiliated investment entities. Although the requests have so far...more

UK FCA Policy Statement on Sponsor Competence and Consultations on Joint Sponsors and Sponsor Conflicts

On September 26, the Financial Conduct Authority (FCA) published consultation paper CP14/21, incorporating its policy statement CP14/02 (sponsor competence) and other changes into the Listing Rules and Prospectus Rules....more

Immigration Alert: September 2014

Sixth Circuit Expands the Liability of Health Care Employers for Sponsorship Costs - On August 20, 2014, the U.S. Court of Appeals for the Sixth Circuit issued its decision in Kutty v. U.S. Department of Labor, No....more

China’s National Auditing Office Notes Compliance Concerns with Sponsorship of Academic Conferences in the Healthcare Sector

In China, it is common industry practice for pharmaceutical companies to sponsor academic conferences. As long as such events are aimed at enhancing the practice of medicine and patient welfare, the practice has been allowed....more

CMS Issues Star Ratings for the 2014 Plan Year

On October 11, 2013, CMS posted the 2014 Medicare Health Plan Quality and Performance Ratings, which are commonly referred to as “Star Ratings.” CMS released the 2014 Star Ratings several days later than originally...more

Outlawing Ambush Marketing

With the 2011 Rugby World Cup (‘RWC’) in New Zealand living up to its billing as the ‘Stadium of Four Million’, the Rugby Football Union and the RWC 2015 Organising Committee have a daunting task ahead of them in exceeding...more

Risk Assessments In An Anti-Money Laundering Compliance Program

Today we celebrate that noted British comedian who made his fame in America – Bob Hope. ...more

Draft Guidance Outlines Recommendations for Formal Meetings Between FDA and Biosimilar Sponsors and Applicants

The U.S. Food and Drug Administration (FDA) recently released the fourth in a series of draft guidance documents on the approval pathway for biologicals that are biosimilar to or interchangeable with a reference biological...more

Tune Up Sign 10: Excessive Sponsorships

You receive frequent requests for sponsorships or advertising opportunities which are primarily granted based upon who has requested the sponsorship (attorney or client). What does this indicate?...more

Consultation Conclusions on the Regulation of Hong Kong IPO Sponsors – The Top Five Things You Need to Know

On December 12, 2012, the Securities and Futures Commission (SFC) published its eagerly anticipated consultation conclusions concerning the regulation of IPO sponsors (the “Consultation Conclusions”). While a more detailed...more

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