Archive for July, 2009
4th National Forum ITAR COMPLIANCE
July 22nd, 2009
in International Trade & Defense, Regulatory & Compliance |
Take away practical tools to overcome complex ITAR compliance
challenges, including:
• Classifying new, innovative technology, software and systems
• Preventing technical data and defense services export violations
• M & A due diligence: Quantifying successor liability risks and remedying
target violations
• Responding to DDTC-mandated independent audits and company visits
• Foreign nationals: Reconciling conflicts with anti-discrimination and privacy
laws, and implementing IT & physical controls
• Voluntary disclosures: Structuring an investigation, drafting a complete report
and the impact on mitigation
There Has Never Been a More Crucial Time to Attend this Event!
ITAR enforcement has become increasingly heavy-handed. DDTC, the Department of Justice, ICE and the FBI are enhancing their interagency cooperation and actively targeting U.S. exporters that violate the strict provisions of the ITAR. Now more than ever, companies that deal with ITARcontrolled items or technical data must ensure that their export practices and global supply chains are in compliance – or risk harsh penalties, and, in some cases, imprisonment.
In the current economic crisis, U.S. exporters cannot afford fatal errors in applying complex ITAR requirements. Protecting your business requires vigilant development,
implementation and monitoring of nothing less than an effective ITAR compliance program. Toward that end, it is crucial to stay up-to-date on the latest regulatory changes, guidelines and enforcement actions, and successfully overcome real-life ITAR compliance challenges that can threaten your bottom line.
At American Conference Institute’s 4th National Forum on ITAR Compliance, an exceptional faculty of senior business, legal and government officials will provide attendees with best practices and crucial updates on civil and criminal ITAR enforcement, licensing and compliance, as well as practical advice on how to successfully implement internal ITAR controls. Topics will include:
• New DDTC Agreement Guidelines, and their impact on licensing and valuation
• How to classify new, innovative technology, software and systems
• Minimizing the risk of technical data and defense services export violations
• Conducting M & A due diligence: Quantifying successor liability risks and remedying target violations
• DDTC company visits: How they differ from audits, and how to prepare
• Recent trends in consent agreements, litigation and penalty amounts
• Foreign nationals: Ensuring ITAR compliance, and working with HR to reconcile conflicts with antidiscrimination and privacy laws
• Implementing IT & physical controls to enhance ITAR compliance
• Voluntary disclosures: Structuring an investigation, drafting a complete report and the impact on mitigation
• What to expect from a DDTC-mandated independent audit in the context of voluntary and directed disclosures
6th National OFF-LABEL COMMUNICATIONS
July 15th, 2009
in Pharmaceuticals / Biotech / Life Sciences |
Pharmaceutical and Medical Device Company’s Guide to
Staying within the legal bounds in a climate of record-breaking settlements
• INCORPORATE lessons learned from staggering recent settlements into compliance policies and procedures
• IMPLEMENT the FDA’s new guidance on scientifi c reprints
• DETECT the current triggers for government investigations and know what
to do if you receive a subpoena
• CONTROL misconceptions and improper conduct by sales reps
• PROVIDE accurate and current assessments of potential off-label risks when
engaging in M&A
• PREVENT MSLs from blurring the line between medical affairs and sales
• MINIMIZE exposure to product liability and consumer class action risks
RECENT SETTLEMENTS HAVE RAISED THE STAKES
Headlines announcing record-breaking fines for off-label promotion have put
the entire industry on notice. And while the huge dollar amounts involved
are attracting wide attention, just as significant are the additional compliance
obligations that are being agreed to as part of the negotiated settlements.
Pharmaceutical and medical device companies are extremely vulnerable with
their global operations under great scrutiny from federal and state prosecutors,
members of Congress, and potential whistleblowers. Being aware of the current
guidelines that regulate and govern off-label communications, including the
new guidance on scientific reprints, is the bare minimum you must do. To
manage off-label risks with confidence and mitigate potential liability, you must
be savvy with regard to what conduct is triggering government investigations
and litigation, and how you need to adjust your compliance efforts and be ready
to defend against any investigation or claim.
DON’T BE THE NEXT TARGET OF OFF-LABEL PROMOTION CLAIMS!
American Conference Institute’s 6th National Pharmaceutical Counsel’s Guide
to Off-Label Communications will provide you with the most up-to-date tools
for tackling these challenges. You will hear about successful compliance plans,
effective business practices, and winning litigation tactics from leading in-house
counsel, compliance and regulatory officers, and expert attorneys who represent
the pharmaceutical industry. In addition, leading government prosecutors will
be on-hand to provide insights on recent government enforcement priorities.
Don’t miss this opportunity to answer your pressing questions and obtain the
information you need from the leading experts in the field, as you network with
your peers and colleagues from across the country. Delegates will also benefit from
the extensive written materials prepared especially for this conference.
12th Advanced Forum on Structuring, Negotiating and Managing Pharma/Biotech Collaborative Agreements
July 14th, 2009
in Pharmaceuticals / Biotech / Life Sciences |
Allocating Risk, Responsibilities & Rewards in Licensing,
Strategic Alliances and Partnering Deals
Leading in-house counsel, licensing and business development executives and
expert attorneys in the field will share their insights and experiences on how to:
• ANTICIPATE emerging trends in investment capital and current deal structuring
• STRENGTHEN market power by ensuring effective due diligence
• NEGOTIATE essential critical terms including built-in milestones to maximize profitability
• DEVELOP strategies to determine the impact of M&A activity and best position
your company for an acquisition
• MINIMIZE risks by clearly defining critical termination terms
• ENSURE effective alliance management
• PROTECT future rights on emerging technologies such as follow-on biologics
Meet the key dealmakers who will launch your company to the next level
and provide the well-needed infusion of capital and products
2009 has ushered in a new paradigm for Pharma/Biotech deal
structuring. The current economic climate has altered both the
approach and management of collaborative agreements and companies
are now struggling to quickly adapt. For Pharma and Biotech companies
to survive and thrive, it has become more essential than ever to not
only cultivate relationships with the key industry players, but also to
maximize the value of the deal and protect your assets by incorporating
the evolving trends into current and future agreements.
Based on extensive research with industry professionals, ACI’s Advanced
Forum on Structuring, Negotiating, and Managing Pharma/Biotech
Collaborative Agreements was designed to provide you with the most up
to date strategic analysis of current deal structuring while also delivering
outstanding networking and business development opportunities to
ensure you walk away with the contacts and intelligence you need to
forge successful new alliances.
An exceptional faculty of diverse speakers will show you how to
develop and cultivate lucrative relationships by sharing strategies on
and solutions for:
• Capitalizing on shifting trends in the venture capital
investment landscape
• Drafting critical termination terms
• Forging and protecting lucrative relationships with investors
• Negotiating partnerships with start-up innovators
and government programs
• Contending with increased pressure from anxious investor’s
seeking an immediate healthy return on their investment
• Redefining alliance management priorities
• Positioning your IP portfolio to increase your market power
• Negotiating milestones into the compensation structure
• Converting a licensing deal into an acquisition
