Archive for November, 2007« Older Entries
Litigation and Regulatory Risk Management for a Rapidly Evolving Landscape
Gain practical information on:
• The effect of Massachusetts v. EPA and other key recent cases on standing, causation, and admissibility of scientific evidence in climate change litigation
• How state and regional initiatives such as California’s AB 32 and the Northeast’s Regional Greenhouse Gas Initiative are changing the GHG regulatory landscape
• GHG class actions: getting a comprehensive grasp of the nuisance and causation issues to be prepared for potential litigation going forward
• Preparing for impending liability claims through analyzing insurance
coverage and risk assessment
As climate change becomes an acknowledged reality, new risks and liabilities are emerging and shaking up the legal landscape. Are you prepared?
It’s a time of rapid change in response to growing concern about climate change.
Class actions have been filed. Many experts are comparing these cases to “big tobacco” or asbestos – a worrisome comparison for potential defendants. In response to these and other trends, energy companies and large manufacturers are working to reduce emissions – and their legal risk, with some even inserting climate change provisions into their contracts. Manufacturers are re-examining their practices. Insurance companies are creating new products to address GHG risk and examining existing products. Virtually every company is examining their “carbon footprint” on some level.
American Conference Insitute’s upcoming conference on Managing the Legal Liabilities and Regulatory Risks of Climate Change is focused on helping corporations minimize litigation and enforcement risks relating to climate change. Whether you are an insurer, in-house counsel with a power company, large manufacturer or other at-risk entity, or a lawyer in private practice, you’ll get valuable, up-to-the minute advice and practical counsel from top experts behind key climate change regulatory developments and litigation.
This is your best opportunity to ensure you have the critical information you need to stay ahead of the curve in this rapidly developing area. Spaces will go quickly for this one-of-a-kind event, so register today. We look forward to meeting you at the conference in New Orleans.
November 15th, 2007
in Pharmaceuticals / Biotech / Life Sciences |
Intensive training in essential pricing concepts, methodologies and strategies
relative to key government payor programs
Leaders in pricing and reimbursement methodologies under key government
payor programs will drill you in the core competencies of prescription drug
pricing and help you:
• UNDERSTAND how price is established and how the rebate system works
• NAVIGATE recent changes in AMP calculations resulting from publication
of the final Medicaid rebate rule
• DEFINE key pricing terms
• MAKE sense of confusing pricing calculations
• MASTER key pricing concepts under the main government payor programs and their interrelation, including:
- AMP, AWP, WAC, BP, WAMP, CPIU, ASP, FCP and non-FAMP
END YOUR CONFUSION NOW!
Pricing in compliance with government payor programs can be difficult and confusing. Not only do you need to know what AMP, AWP, WAC, BP, ASP, non-FAMP, and FCP mean, but you need to understand how all of your prices are related. A change in price to one customer can adversely effect your prices to other customers or the rebates you have to pay. To add to the confusion, CMS’s
publication of the final Medicaid reimbursement rule changes the definition of AMP and the reimbursement formula for generic drugs.
A strong grasp of pricing methodologies, calculations and reporting requirements under programs such as Medicaid, Medicare, VA/DoD and PHS is critical to maximizing revenue and profits when working with government payor programs. Understanding the fundamentals of AMP, AWP, WAC, BP, ASP, non-FAMP, and FCP will make pricing calculations less confusing and less time consuming and will help to prevent pricing and reporting mistakes that can lead to fraud and abuse allegations.
MASTER THE ESSENTIALS OF KEY PRICING CONCEPTS
ACI’s Rx Drug Pricing Boot Camp has been designed to give novices and experienced practitioners alike a complete understanding of core pricing competencies and applicable changes in reimbursement structures of key payor programs under recently enacted legislation with a strong focus on the final
Medicaid rule recently issued by CMS. Take this unique opportunity to discuss with pricing experts and fellow pricing professionals the challenges faced and solutions discovered after the first quarter of price reporting under the new Medicaid rebate rule. Topics that will be discussed include:
• AWP: what is it, when it is still used, and what effect will litigation have on the continued use of this pricing methodology?
• AMP: how is this price now calculated, and what is included in and excluded from the calculation
• Part D pricing challenges and strategies for success
• Fraud and abuse concerns arising under Medicare Part D
Making the Right Choices | Profiting from Opportunities | Building a Winning Strategy
The premier event for business leaders . Senior-level networking with developers, owners, investors, and managers.
Industry experts will show you how to:
• CHOOSE the right development options
• SET your branding strategy
• NEGOTIATE franchise and operating agreements
• CREATE a winning marketing approach
• OVERCOME challenges presented by slow-selling projects
While some condo hotel developers are looking to expand, others are moving slowly or shifting their strategies.
What is really going on and how can you operate
profitably in this market?
About 59,000 condo hotel rooms are currently in development (according to Smith Travel Research) and developers such as Trump, who plans to open nine new properties (as reported in GlobeSt.com on June 28) are pushing ahead aggressively with new projects. On the other hand, predictions that the majority of new hotels would have a condo component are proving to be false, and there is a great deal of uncertainty over the current state of the market.
Was there too much growth too fast? Which markets are ripe for new projects?
What mistakes have some developers made? What are the options for turning around projects that are suffering from stagnant sales?
ACI has developed its Condo Hotel Summit to address the pressing need for clear
guidance as developers and investors sort their options and decide what types of projects warrant new investment, and how to make sure that finished projects and those in the pipeline are successful. This event will offer practical discussion of real-world issues that are arising in different types of properties and sales environments, and offer solutions to the problems that you may already be facing or need to be prepared for.
Our faculty, consisting of leading experts and advisors for major hospitality companies as well as for property developers and investors, will offer key negotiating advice and detailed knowledge to help you better handle various types of transactions. They will guide you through:
• Finding the best financing strategies for hotel projects
• Assessing whether or not to “brand” your property
• Selecting the right people to collaborate with
• Negotiating equitable operating agreements
• Repositioning properties to boost sales
• Avoiding risks under the securities laws
• Protecting assets and restructuring loans
Plus, don’t miss our unique in-depth workshop on “Converting from Hotel or
Condo to Condo Hotel” that will take you through the planning, financing and
operational considerations that determine how you should best go forward with
your conversion project.
RESPONSIBLE MORTGAGE LENDING Compliance and legal strategies to prevent claims of predatory lending and other discriminatory practices
Learn best practices for complying with the newest regulations:
• Federal and State enforcement officials’ views on emerging initiatives and impact on the predatory lending landscape
• Assess the impact of Watters and the status of pre-emption on lending practices
• Ensure “clear and balanced” disclosure information to consumers
• Evaluate the consequences of heightened due diligence by the secondary market
• Properly structure your department to account for the changing
Hear directly from State and Federal Officials from:
Office of Thrift Supervision, Federal Trade Commission, California Department of Justice, North Carolina Office of the Commissioner
With the market in flux, states and individuals are aggressively targeting lending practices…Is your anti-predatory compliance program prepared to withstand this increased scrutiny?
Lately, it’s hard to keep up with the emerging initiatives impacting the mortgage lending industry. Foreclosures are at a 50 year record high, enforcement actions are on the rise, and tracking new state requirements and complying with the proposed interagency guidance may seem like an insurmountable task.
Given its position at the epicenter of the so-called “mortgage melt-down”,
the sub-prime market is facing even greater scrutiny.
With this intense focus, it is more important than ever to re-evaluate your controls and procedures to ensure strict adherence to local, state and federal anti-predatory and fair lending legislation and guidelines.
By attending ACI’s 10th Annual Forum on Responsible Mortgage Lending (formerly monikered “Predatory Lending”), you will obtain all the practical insights and information you need to keep your lending program in compliance with ever-evolving anti-predatory lending requirements.
Our expert faculty will provide insights on:
• Emerging state legislation initiatives across the nation
• Evaluating the impact of sub-prime mortgage litigation on the predatory lending landscape
• Assessing the structural changes across the industry and its impact on compliance activities
• Ensure disclosure compliance to avoid TILA violations
• Understanding the limitations of loan repurchase in the secondary market
In addition we offer two unique workshops to customize your conference experience: Mortgage Regulation Primer: Rules, Restrictions and Requirements for State Regulated and Federally Chartered Mortgage Lenders, before the main event to bring those new to the area up to speed and Conducting a Self-Assessment of Your Anti-Predatory Lending Compliance System, for those looking for additional insight on how to analyze the effectiveness of your overall compliance program.
November 13th, 2007
in Pharmaceuticals / Biotech / Life Sciences |
Allocating Risk, Responsibilities & Rewards in Licensing,
Strategic Alliances and Partnering Deals
Leading in-house counsel, business development executives and expert attorneys in the field will show you how to:
• INCORPORATE new laws and trends into business strategies to ensure successful and lucrative collaborations
• MAXIMIZE value by selecting the most viable deal and compensation structures
• SAFEGUARD intellectual property rights in the agreement
• MINIMIZE risks through effective due diligence
• ENSURE effective alliance management through workable governance processes
• ANTICIPATE the impact of generics
• DRAFT useful termination provisions
• PROTECT the company and IP in the event of a change of control
• AVOID the top ten pitfalls with international deals
John A. Hurvitz
Partner, Covington & Burling LLP
Executive Director, Healthcare
Innovation, AstraZeneca LP
It is clear that in today’s environment, both pharmaceutical and biotech companies must rely on licensing and collaborations to ensure their survival. However, negotiating and maintaining win-win agreements is also becoming more difficult as competition increases, laws change, and the deals become more complex. Selecting the right partners, deal structure and compensation analysis are crucial to the success of the deal and an assessment of these factors must be done early in the process.
Translate new laws and trends into a winning business strategy
Recent proposed legislation regarding follow-on biologics as well as Supreme Court decisions in MedImmune v. Genentech and KSR v. Teleflex can change the value of the intellectual property involved in the collaboration. You need to take into account this changing legal environment in order to negotiate the best deal
available for your company’s needs. In addition, as more of these deals morph into M&As, you need to adjust your negotiation strategies accordingly.
Ensure your agreements lead to positive outcomes
Developing a workable alliance management plan is essential to a successful and lucrative deal. And should the deal fall through, as many do, it is imperative that you have protected your IP and drafted termination provisions that allow both parties to walk away with their assets intact.
Also, add significant value to your experience by attending our Master Class: The “Win-Win” Collaborative Agreement: Ethical and Practical Negotiating and Drafting Strategies. This thorough and hands-on session will be led by experts in the field who will give you practical and detailed instruction on how to negotiate
and draft the most effective and ethical collaborative agreements.
November 13th, 2007
in Energy & Resources |
Exploiting the Commercial Viability of CCS: Stake your Position to Capitalize on Future Revenues
ATTEND THIS CONFERENCE TO:
■ EXPLORE global CCS activity to leverage effective funding
and deployment strategies to your advantage
■ UNDERSTAND why now is the right time to capitalize on CCS
■ CAPITALIZE on the financial and regulatory incentives offered by the new
Texan Advanced Clean Energy Bill
■ EXAMINE innovative methods to offset costs and increase the investment
potential of CCS
■ OVERCOME obstacles ranging from liabilities to gaining public acceptance
of CCS so that you can take advantage of an industry on the cusp!
With the world facing a major climate crisis, controlling the amount of CO2
released into the atmosphere is crucial. CO2 is the number one contributor to
greenhouse gases and thus a significant factor in climate change. But coal plants
are still heavily in use today and their popularity is growing in the developing world, where they are seen as a quick, easy and relatively inexpensive solution to their overwhelming energy needs.
How can we balance the world’s energy demands, with the necessity to protect
the environment and reverse some of the damage that has already been done?
The answer is Carbon Capture and Storage.
New advances in Carbon Capture and Storage (CCS) are not only helping
to alleviate this negative environmental trend, but presenting significant
CCS is on the cusp of commercial viability. Stake your position now by attending
ACI’s inaugural Carbon Capture and Storage conference which brings together
industry thought-leaders to truly demonstrate the emerging business opportunities and long-term investment returns.
Speakers include: Department of Energy, Department of Energy (DOE)
Regional Partnerships, FutureGen, Hydrogen Energy (the joint venture of BP
and Rio Tinto), American Electric Power, The Senate Committee on Energy
and Natural Resources, Denbury Resources, Clean Coal Technology Foundation
of Texas (CCTFT), Texas House Energy Committee, Melzer Consulting and
The University of Texas at Austin,
Make the most of your conference experience by registering for our interactive
post-conference workshop ‘Quantifying the Financial Benefits of Using CO2
for Enhanced Oil Recovery’.
Who You Will Meet:
• Senior Executives from Energy Companies, including Vice-Presidents
and Directors of Energy and Carbon Services
• Top Federal and State Government Representatives
and Regulatory Agencies
• Investors including PE funds, hedge funds, and investment banks
• Key industry players from oilfield service providers, technology companies, and manufacturers
• Leaders involved in the DOE Regional Partnership and FutureGen
• Esteemed Scientists and Academics from several prominent institutions
• Experts from Environmental NGO’s
• Partners and Associates from law firms with climate change practices
THE PREMIER LEGAL & REGULATORY ANTI-CORRUPTION COMPLIANCE EVENT
CRUCIAL IN-HOUSE INSIGHTS FROM:
An FCPA enforcement explosion is reaching across industries and around the globe. 2007 has already produced both the largest criminal fine and the largest combined sanction ever imposed for violations of the FCPA. Recent settlements of FCPA actions have resulted in heavy civil and criminal penalties for both individuals and corporate offenders, disgorgement of profits and, increasingly, the imposition of independent monitors. Foreign governments, primarily in Europe, are also cracking down on corruption and actively cooperating with US
enforcement officials. Companies today face not only FCPA enforcement actions in the United States, but the possibility of enforcement actions in other jurisdictions as well.
The increase of FCPA enforcement makes prevention an even higher priority than it may have been in the past. The absence of preventative measure is almost certain to result in substantially increased penalties if an issue arises. This makes an effective anti-corruption compliance program essential for all companies. With record-setting sanctions involving well-known companies, global organizations have to reassess their own anticorruption measures to prevent lapses that might lead to damaging and costly enforcement actions.
Now in its 18th successful year, the American Conference Institute’s National Conference on the FOREIGN CORRUPT PRACTICES ACT is the event that corporate counsel, compliance officers, outside counsel and consultants
rely on for comprehensive, insightful, and practical guidance on critical FCPA compliance issues. Benefit from the practical perspective of seasoned corporate FCPA compliance executives, get an update on enforcement and policy initiatives from top Government officials and FCPA attorneys, and learn how industry is setting up internal controls to comply in this constantly changing global legal landscape. This year’s agenda will include the latest information on:
• Changes you need to make to your compliance program as a result of recent cases against companies and individuals
• How government agencies evaluate voluntary disclosures
• Harmonizing U.S. and foreign anti-corruption compliance obligations
• How to design and implement due diligence for a prospective foreign third party relationship
• What to look for in a target’s anti-corruption compliance
• Managing the PR impact of an investigation or voluntary disclosure
• How to incorporate robust FCPA auditing into your compliance program
November 13th, 2007
in Energy & Resources |
Capitalizing on Innovative Financing Options and
Risk Management Strategies to Maximize ROI
Timothy Alan Simon
PAUL HASTINGS, WALKER & JANOFSKY LLP
Renewables, GE ENERGY
Leading project finance experts and developers will share their experiences and provide unrivaled insight into:
• Identifying and Evaluating Current Market Conditions for Developing
Renewable Energy Projects
• Getting Your Project Financed Using Performance Bonds, Renewable Energy Credits and Guarantee Programs
• Sourcing Renewable Energy Debt Financing
• Using Tax Credits to Efficiently Structure and Finance your Project
• Current Renewable Energy RFPs
• Leveraging Energy Efficiency Strategies to Enhance Renewable Energy Projects
• Environmental Issues for Renewable Energy Projects
• Assessing and Mitigating the Various Risk Factors Specific to Renewable Energy Projects
The market for renewables is growing every day and has been estimated to be worth $1.9 trillion by 2020. There is no doubt that renewable energy will have to supply a greater portion of the world’s energy supplies. Renewable projects however, have a variety of constraints and intrinsic economics very different from conventional thermal energy projects.
To gain maximum benefit from the boom in renewables, developers and their advisers need a unique opportunity to network with key players from both public and private sectors including large group of developers, lenders, investors, and experts who share similar concerns.
ACI’s inaugural conference on Financing Renewable Energy Projects brings together a pool of experts who have worked in this field in one capacity or another and are more than willing to share their winning strategies with you. The conference includes two days of in-depth coverage on how to structure a renewable deal to best gain access to financing and case studies on how to overcome the hurdles that arise in real world projects.
The pre-conference symposium day features a comprehensive look at the “Fundamentals of Project Finance” that need to be addressed when financing a project. The stellar speaker faculty will contribute to your knowledge of financing renewable and in particular:
• Hear Commissioner Simon’s view on CA’s initiatives towards renewable energy projects
• Don’t miss Michael Bruce from the DOE talk about realizing the value of America’s federal energy R&D investment
• Hear Shell & LADWP talk about issues you don’t want to miss when
constructing an RFP
• Attend City National Bank’s session to learn more about how to source renewable energy debt financing
• See what William Garnett from National City Energy Capital means when he
says lease tax to finance renewable projects
Learn best practices from leading medical device practitioners, in-house counsel and compliance officers on how to:
-TACKLE compliance challenges in light of increased government scrutiny
-MINIMIZE exposure to off-label promotion liability
-AVOID anti-kickback claims that can arise from interacting with healthcare
-IMPLEMENT procedures to account for new state law initiatives
-STEER CLEAR of fraud and abuse risks associated with discounting,
bundling and pricing
-DEVELOP a plan of action for responding to subpoenas
-UTILIZE smart and safe direct-to-consumer advertising practices
-PREVENT risks associated with vendor credentialing
-DEVISE successful real world implementation strategies for industry
Government agencies, enforcers and the media have all recently suggested that medical device companies will increasingly be the target of fraud and abuse investigations. In addition to the typical sales and marketing activities that have triggered enforcement in the past, i.e. off-label promotion, consulting agreements and direct-to-consumer marketing – medical device companies now have to contend with fraudulent allegations involving joint ventures and vendor credentialing. The possibility of steep fines and highly publicized and expensive litigation only adds fuel to the fire.
Reduce risk with an effective compliance program
Having corporate policies in place just isn’t enough anymore in this time of increased public and private scrutiny. Developing an ethical compliance infrastructure is an essential competency to decreasing the risk of qui tam litigation. You need to be able to monitor, audit, and measure the effectiveness of the compliance program to ensure its success.
The American Conference Institute has developed the 6th National Conference on Reducing Legal Risks in the Sales and Marketing of Medical Devices to provide you with a sophisticated and comprehensive understanding of the most difficult and costly dilemmas facing device companies today, along with practical strategies for tackling these challenges.
Add value to your attendance by taking advantage of our interactive and in-depth Workshop on Off-Label Promotion of Medical Devices: Avoiding False Claims Act Scrutiny. This hands-on workshop will provide you with the tools you need to avoid the exposure and costs associated with false claims liability for improper off-label communications.
Clear cut strategies with detailed examples
for reducing fraud without increasing costs
Gain insight and share ideas with fraud prevention and quality assurance experts as well as senior mortgage banking attorneys in this interactive seminar focusing on how to:
• INVESTIGATE and thwart large scale and increasingly sophisticated schemes to commit mortgage fraud
• RESOLVE and contest repurchase requests
• INCORPORATE the newest technology tools into your fraud management arsenal
• COMPLY with the myriad of new state laws dealing with stated income loans and non-traditional product offerings
• PREVENT infiltration by unlicensed brokers and “bad” loan officers
• CONVINCE and work with law enforcement to prioritize resolution of your fraud case
• MAXIMIZE recovery from all sources
Losses From Mortgage Fraud Totaled $4.2 Billion in 2006 . . .
How Much of That Came Out of Your Company’s Pocket?
Mortgage fraud continues to grow at an alarming rate and shows no signs of abating. According to FBI statistics, mortgage fraud increased 62% from 2005 to 2006, based on the number of SARs that were filed. And, given the increasingly elaborate fraud schemes that are emerging, it is becoming harder than ever to develop effective preventive strategies. In this environment, it is more important than ever for mortgage lenders to stay ahead of the curve by learning the most up-to-date techniques to prevent and fight mortgage fraud.
At American Conference Institute’s 4th National Forum on Preventing and
Resolving Mortgage Fraud, you will hear from a leading faculty of experienced
quality assurance and fraud professionals as well as senior mortgage banking
attorneys. They will provide you with effective techniques on how to:
• Detect common characteristics of fraud during the pre-funding stage
• Identify the best sources of recovery
• Keep costs down when utilizing automated systems to detect fraud
• Prevent fraud involving the closing agent
• Understand what loans investors are – and aren’t – buying