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NUCLEAR EXPORT CONTROLS

November 30th, 2010
in Energy & Resources |

A rare opportunity to hear directly from the U.S. Department of Energy, U.S. Nuclear Regulatory Commission, and the U.S. Department of Commerce on complex nuclear export control regulations, ACI’s Advanced Summit on Complying with Nuclear Export Controls will provide you with firsthand insights directly from the government on how to navigate the arduous regulatory and compliance challenges associated with the export of nuclear items, services and technologies.

Attendees of this conference will learn how to master such complex topics as how to:

    • Determine jurisdiction and classification under NRC, DOE and BIS export control regulations
    • Address unique issues raised by the “transfer” of nuclear technology to foreign national employees
    • Obtain required nuclear licenses and authorizations
    • Mitigate deemed export violations
    • Implement an effective global compliance program for nuclear products, technology and services

Also benefit from special update panels on:

  • French & Japanese Regulations on Nuclear Exports, featuring insights from Areva & Hitachi
  • Nuclear Export Enforcement, featuring insights from David Jonas, General Counsel, National Nuclear Security Administration, U.S. Department of Energy

Included as part of the registration fee are in-depth conference materials that can be utilized as a continuous resource and desk reference after the conference. Learn how your peers are confronting the same challenges you face on a day-to-day basis.

If you are involved at all in the area of nuclear export controls, this is one event you don’t want to miss!

Interactive Working Group Sessions:

(A) The Fundamentals of Nuclear Export Control Regulations
(B) Nuclear Plant Operations 101: What Every Export Controls & Compliance Officer Needs to Know About How a Nuclear Reactor Works

BIOTECH PATENTS

November 30th, 2010
in Pharmaceuticals / Biotech / Life Sciences |

ACI’s Forum on Biotech Patents will unveil comprehensive and practical biotech patent prosecution and litigation strategies for a rapidly evolving legal climate

Investing just 2 days in this conference will enable you to:

  • Ensure maximum patent life for your biologic. Leading expert in-house and outside counsel will share with you the claim drafting strategies that are narrow enough to be approved, yet broad enough to prevent infringement.

  • Determine the best strategies to put in place in your claims to protect your international IP portfolio

  • Develop an International patent strategy to maximize market share in a global economy

  • Formulate an emergency strategy to brace for the flood of litigation that is sure to come now that the reality of follow-on biologics is here. Brainstorm with innovators, generic brands, and policy makers from BIO to come up with a winning strategy to put in place immediately in the face of this groundbreaking legislation.

  • Take a look at biosimilars around the globe: find out how other countries are implementing abbreviated pathways and to what success rate
    • Learn how to successfully incorporate the new PTO initiatives to benefit workflow and prepare for any potential challenges. Directly address your questions and concerns to keynote speaker Sharon Barner, Under Secretary of Commerce for Intellectual Property and Deputy Director of the United States Patent Trademark Office.

    ….and much more

    China Forum on Import Compliance

    November 30th, 2010
    in Regulatory & Compliance |

    ACI’s Advanced China Forum on Import Compliance is Only 3 weeks away! Registrations are coming in fast. Reserve your place today!

    This is the Advanced China Import Conference that everyone is talking about. This one of kind event features an exceptional speaking faculty of more than 20 multinational companies present corporate strategies on complying with the latest China customs, AQSIQ and MOFCOM import regulations.

    Co-chaired by Donna Dong, Group Trade Manager- Asia Pacific from Microsoft and Shubhendu Misra, Customs Director from General Motors, the program agenda will cover the most pressing China import issues, including:

    • Develop and implement a robust internal import compliance program for your China operations
    • Calculate royalty payments in customs valuation
    • Obtain AQSIQ import licenses for used equipments
    • Manage customs handbook reconciliation and balancing
    • Handle customs compliance for bonded international repair centers
    • Prepare for customs audits and investigations
    • Maximize duty-saving opportunities offered by China’s FTA
    • Customize an internal tariff classification system for China operations
    • Comply with CCC mark requirements
    • Optimize bonded operations process
    • Obtain permits when importing encryption products
    • Manage customs brokers compliance

    BAD FAITH LITIGATION

    November 30th, 2010
    in Litigation |

    The essential forum that shapes the future of bad faith litigation strategies for leading outside counsel and claims examiners in the insurance industry

    We are just 4 weeks away from the definitive forum on litigating today’s key issues involving bad faith claims.  More than 50 law firms and 20 insurance companies already sending an attorney(s) to this event and we noticed you haven’t signed up yet. Your colleagues have signed up early for this critical event and there are no signs of registration slowing down. Join them by registering today and locking in the $2095 rate, which expires Friday, 11/19.  Tolockin this rate, mention keycode “BDF” when registering to receive a discounted rate of $2095 and save $200 off the full conference price.

    Register today to hear novel and ground breaking insights on:

    · Claims examiner and in-house counsel insights

    · The view from the policy-holder’s bar and where they think claims are headed in the year ahead

    · In-house strategies for preventing bad faith claims

    · Considerations when settling bad faith claims

    · Pinpointing the bad faith setup before a claim is filed

    · Pre-trial strategies for defending against bad faith claims and

    · Limiting the scope of discovery

    · Preparing company witnesses for depositions

    · Dealing with claims related to catastrophic disasters

    …and much more

    NUCLEAR EXPORT CONTROLS

    November 30th, 2010
    in Energy & Resources |

    In just a few weeks, more than 70 of your in-house peers and representatives from the Department of Energy, Nuclear Regulatory Commission, and the Department of Commerce will be meeting in Washington, DC to discuss and share best practice for Complying with Nuclear Export Controls.

    Hosted by the American Conference Institute and taking place on November 30-December 1 at the Westin Washington DC Center, this industry leading event will feature representatives from the government including:

    David S. Jonas, General Counsel, NNSA, U.S. Department of Energy

    Richard S. Goorevich, Director, Office of International Regimes and Agreements, U.S. Department of Energy

    Scott Moore, Deputy Director, Office of International Programs, U.S. Nuclear Regulatory Commission

    Steve Claggett, Director, Office of Missile Technology & Nuclear Controls, BIS, U.S, Department of Commerce

    Benchmark with your peers on the leading edge of the nuclear industry from Areva, Constellation Energy, Flowserve, GE Hitachi, Hitachi Power Systems America, New Brunswick Laboratory, QSA Global, Transco Products, USEC and Westinghouse Electric.

    A rare opportunity to gain firsthand insights directly from the government while also learning how to best develop your internal trade compliance program in order to:

    • Accurately determine jurisdiction and classification under NRC, DOE and BIS export control regulations
    • Address unique issues raised by the “transfer” of nuclear technology to foreign national employees
    • Obtain required licenses and authorizations
    • Mitigate the risk of third party violations

    Also benefit from special sessions included as part of the conference on:

    • Nuclear Export Control Regulations in France and Japan
    • How to Access Nuclear Business Opportunities in China, India and the U.A.E.

    D&O Liability

    November 30th, 2010
    in Insurance & Reinsurance |

    The D&O liability insurance market has been in a state of flux, to say the least.  The FDIC is aggressively pursuing claims against executives from failed financial institutions. At the same time, the SEC remains aggressive and shareholders continue to bring securities class actions and derivative suits.  Claims are coming from multiple directions at an increasing rate. What impact does this activity have on the market? How far does coverage extend? Where are claims headed? What coverage is out there?

    Don’t miss out on the event all of your peers in the industry will be talking about. Register today tonetwork with leading D&O insurance professionals and counsel and to obtain expert guidance on:

    - ADAPTING to a changing market and new policies

    - UNDERSTANDING the expectations and concerns of companies in their D&O policies

    - DEFENDING against the continued onslaught of securities class actions and an increasing number of shareholder derivative suits

    - EVALUATING the impact of financial institution litigation on the market, including the FDIC’s recent activity

    - RESPONDING to increased regulatory scrutiny

    - NEGOTIATING favorable settlement terms that all sides can agree on

    BIOTECH PATENTS

    November 30th, 2010
    in Pharmaceuticals / Biotech / Life Sciences |

    Be first among your peers to discuss the recent developments at the two-day FDA hearings on the follow-on biologic approval pathway with the generic and branded companies and policy makers who will be instrumental in shaping the law.

    Generic biologics have been long-speculated in the industry, but with the hearings, the FDA has taken a concrete step towards making the implementation of follow-on biologics a reality. Gain insights directly from the industry leaders about the serious questions remaining in the wake of Congress enacting an abbreviated pathway for second-generation biologic products:

    • How will the FDA approach the approval process?
    • What will constitute interchangeability and substantial equivalence?
    • Will safety and efficacy data from clinical trials be extrapolated?

    Featuring a focus session on follow-on biologics, leading in-house counsel and top-notch biotech lawyers will offer thoughtful and targeted commentary on these open questions and help you brace for the flood of litigation that is sure to come now that the reality of follow-on biologics is here.

    Additionally, attendees will gain practical tips on:

    • Streamlining the patent approval process and benefiting from the new PTO initiatives. Get the ultimate insider’s view into the United States Patent Trademark Office through keynote speaker Sharon Barner, Under Secretary of Commerce for Intellectual Property and Deputy Director of the United States Patent Trademark Office.

    • Protecting your IP cornerstones including gene patents and method patents. Formulate an emergency triage plan to have in place immediately to ensure your intellectual property cornerstones are indeed protected in the wake of the Supreme Court’s decision in Bilski and the looming Federal Court decisions in Prometheus, Classen, and Myriad.

    • Maximizing market share and securing enforcement of biotech IP in a global economy. Featuring two sessions on formulating a comprehensive international patent strategy, our expert faculty of practitioners on the frontlines in the EU, China, and India will give you drafting and prosecution tips to break into and protect patents in these key jurisdictions.

    …and much more

    BIOTECH PATENTS

    November 30th, 2010
    in Pharmaceuticals / Biotech / Life Sciences |

    Your attendance will enable you to:

    • Get the ultimate insider’s view into how to benefit from recent PTO initiatives including the Patent Prosecution Highway and the three-track system. Come prepared for the chance to directly address your questions and concerns to keynote speaker Sharon Barner, Under Secretary of Commerce for Intellectual Property and Deputy Director of the United States Patent Trademark Office.

    • Benchmark with industry leaders who will help you implement a step-by-step action plan to ensure your intellectual property cornerstones are indeed protected in the wake of the Supreme Court’s decision in Bilski, and the looming Federal Court decisions in Prometheus, Classen and Myriad. Network with an outstanding faculty including:

    Merck & Co, Inc.  * Abbott Laboratories * Novartis Institutes for Biomedical Research, Inc.* Cubist Pharmaceuticals, Inc. * ZymoGenetics, Inc. * Novartis Pharmaceuticals * Biovail Laboratories International * Immunogen, Inc. * Emergent BioSoutions * Dicerna Pharmaceuticals

    • Formulate an emergency strategy to brace for the reality of follow-on biologics now that the FDA has taken a concrete step in approaching the approval pathway. Brainstorm about developments at the two-day FDA hearings on the follow-on biologic approval pathway with the innovators, generic brands, and policy makers from BIO who are instrumental in shaping the law.
    • Maximize market share and securing enforcement of biotech IP in a global economy. Featuring two sessions on formulating a comprehensive international patent strategy, our expert faculty of practitioners on the frontlines in the EU, China, and India will give you drafting and prosecution tips to break into and protect patents in these key jurisdictions.
    • Ensure your intellectual property is protected in our highly interactive and hands-on Master Class on Drafting and Prosecuting Successful Patent Applications in the US and Abroad in an Evolving Biotech Patent Landscape. Leading in-house counsel and global and domestic practitioners from top law firms will take you through a step-by-step application of the skills you have garnered in the past 2 days of the conference in a mock drafting scenario.

    The hypothetical mock drafting scenario will give you the opportunity to:

    • Draft successful patent applications in the face of statutory and judicial uncertainty
    • Have your hypothetical applications critiqued by industry leaders
    • Ensure your intellectual property is protected from the get-go through strategic decision making
    • Brainstorm with and learn from your fellow industry leaders in a collegial environment

    Get your plan in place immediately to protect your existing patents from attack. The stakes are too high to miss out on this opportunity to hear targeted commentary from the leading in-house counsel, policy makers and top-notch biotech lawyers who are driving the industry.

    PRIVACY & SECURITY OF CONSUMER AND EMPLOYEE INFORMATION

    November 19th, 2010
    in Employment & Benefits |

    Protecting and Managing Sensitive Data While Adapting to Heightened Regulatory Scrutiny, Technological Advancements and a Global Marketplace

    There is bipartisan support in Washington for implementing more stringent privacy and information security oversights. Federal and state regulators continue to aggressively pursue companies for privacy missteps, with the FCC being the latest agency to join the fray.  Companies of all types are finding themselves struggling to keep up, and the stakes are high as failures to protect the sensitive information of consumers and employees can result in billions being lost in the form of legal fees, regulatory penalties, and loss of business and consumer trust.

    As the risks continue to evolve, the dangers of a breach increase and regulators grow more concerned, companies and their counsel mustbe prepared for whatever is next on the horizon . . .

    ACI’s 10th Annual Legal and Compliance Forum on Privacy & Security of Consumer and Employee Information (January 25-26, 2011 in Washington, D.C.) has been the premier forum for those in the field to come together and share high level discussion on the regulatory, legal, and compliance issues impacting privacy & information security professionals. Now in its 10th year, the program has been fully revised and updated to account for the major changes impacting this complex and evolving area.

    • ADAPTING to heightened regulatory scrutiny from federal and state agencies
    • PREPARING to face new privacy concerns posed by behavioral advertising and social networking
    • UNDERSTANDING the full effect of the HITECH Act, and how it impacts more than the healthcare industry
    • DEVELOPING effective workplace privacy policies both for on-site and mobile workforces
    • PREVENTING and responding to data breaches in a global marketplace
    • IMPLEMENTING an effective multinational privacy program


    What’s in a Name Under the FCPA

    November 17th, 2010
    in Anti-Corruption / FCPA, Expert Guest Blog Entries |

    What is in a name? The terms agent, reseller and distributor are sometimes used interchangeably in the business world. However in the legal world they usually have distinct definitions. An agent can be generally defined as is a person who is authorized to act on behalf of another to create a legal relationship with a Third Party. An agent can also be a person who makes introductions and generally facilitates relationships between the seller of goods or services and end-using buyer. Such an agent usually receives some type of percentage of the final sale as his commission. An in-country national agent is often required in most Middle East and Far East countries. A reseller can be generally defined as a company or individual that sells goods to an end-using buyer. A reseller does not take title and thereby own the goods; the reseller is usually a conduit from the seller to the end-using buyer. A reseller usually receives a flat commission for his services, usually between 5-10% of the final purchase price. This format is often used in the software and hardware industries. A distributor can be generally defined as a company or individual which purchases a product from an original equipment manufacturer (OEM) and then independently sells that product to an end user. A distributor takes title, physical possession and owns the products. The distributor then sells the product again to an end-using purchaser. The distributor usually receives the product at some discount from the OEM and then is free to set his price at any amount above what he paid for the product. A distributor is often used by the US manufacturing industry to act as a sales force outside the US.

    The landscape of the Foreign Corrupt Practices Act (FCPA) is littered with cases involving both agents and resellers are they are the most clearly acting as representatives of the companies whose goods or services they sell for in foreign countries. However many US businesses believe that the legal differences between agents/resellers and distributors insulate them from FCPA liability should the conduct of the distributor violate the Act. They believe that as the distributor takes title and physical possession of the product, the legal risk of ownership has shifted to the distributor. If the goods are damaged or destroyed, the loss will be the distributor’s not the US business which manufactured the product. Under this same analysis, many US companies believe that the FCPA risk has also shifted from the US company to the foreign distributor. However such belief is sorely miss-placed.

    As almost everyone knows, the FCPA prohibits payments to foreign officials to obtain or retain business or secure an improper business advantage. But many US companies view distributors as different from other types of sales representatives such as company sales representatives, agents, resellers or even joint venture partners, for the purposes of FCPA liability. However the Department of Justice (DOJ) takes the position that a US company’s FCPA responsibilities extend to the conduct of a wide range of third parties, including the aforementioned company sales representatives, agents, resellers, joint venture partners but also distributors. No U.S. company can ignore signs that its distributors may be violating the FCPA. Company management cannot engage in conscious avoidance to the activities of a distributor that the company has put into a business position favorable to engaging in FCPA violations. Court interpretation of the FCPA has held that it is applicable where conduct violative of the Act is used to “to obtain or retain business or secure an improper business advantage” which can cover almost any kind of advantage, including indirect monetary advantage even as nebulous as reputational advantage.

    This scenario played out in China from 1997 to 2005 through AGA Medical Corporation. The Minnesota-based firm manufactured products used to treat congenital heart defects. To boost is China sales, AGA worked through its Chinese distributor. AGA sold products at a discounted rate to its Chinese distributor. This distributor then took some of the difference between his price from the equipment manufacturer AGA and the price he sold the equipment to Chinese hospitals to and paid corrupt payments to Chinese doctors to have them direct their government-owned hospitals to purchase AGA’s products. Its sales in China for the period were about $13.5 million. The Chinese distributor was found to have paid bribes in China of at least $460,000 to doctors in government-owned hospitals and patent-office officials. In 2008, AGA agreed to pay a $2 million criminal penalty and enter into a deferred prosecution agreement with the Department of Justice to settle Foreign Corrupt Practices Act violations.

    The same game was played by a Volvo subsidiary, Volvo Construction Equipment International (“VCEI”) when it used a Tunisian distributor to facilitate additional sales of its products to Iraq. VCEI reduced its prices to enable the distributor to make the illegal payments based on bogus after-sales service fees. Volvo’s 2008 settlement with the SEC included an agreement permanently enjoining it from future violations of Sections, ordering it to disgorge $7,299,208 in profits plus $1,303,441 in pre-judgment interest, and to pay a civil penalty of $4,000,000. In addition to this fine imposed by the SEC, Volvo also paid a $7,000,000 penalty pursuant to a deferred prosecution agreement with the DOJ.

    So what is in a name? Do we simply look to Shakespeare and his immortal words, “”What’s in a name? That which we call a rose; By any other name would smell as sweet.” Unfortunately I do not think the answer is quite so ethereal. It is more down to earth. If it walks like a duck and quacks like a duck, it probably is a duck. If you have a distributor, it must be subjected to the same FCPA scrutiny and management as an agent, reseller or joint venture partner.

    This publication contains general information only and is based on the experiences and research of the author. The author is not, by means of this publication, rendering business, legal advice, or other professional advice or services. This publication is not a substitute for such legal advice or services, nor should it be used as a basis for any decision or action that may affect your business. Before making any decision or taking any action that may affect your business, you should consult a qualified legal adviser. The author, his affiliates, and related entities shall not be responsible for any loss sustained by any person or entity that relies on this publication. The author can be reached at tfox@tfoxlaw.com.
    © Thomas R. Fox, 2010
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