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Join our Linkedin group for a good cause

December 14th, 2010
in Financial Services, Surveys and Polls |

Active from December 14th 2010- December 31st 2010.

In spirit of the holidays we are going to donate $1 (up to $1000) to a MFI for every new member that joins our linked group, Microfinance Leadership. We are not done just yet. In addition to donating for a good cause, you’ll receive a gift from us! All new members will get a PowerPoint or PDF presentation from our 3rd annual Global Microfinance Investment Congress.

Follow these easy steps:

1. Join our Microfinance Leadership group on Linkedin.
Dont forget to mention “ACIblog” in a message to the group owner.

2. Tell your colleagues, so they can get a PowerPoint/ PDF presentation too! Tell them to mention “ACIblog” in a message to the group manager to be counted as a new member towards our donation.

3. After January 1st, we will post a poll comprised of 5 MFI’s for you to choose from. The highest number of votes will take the donation.

Legal Conferences

The Life Sciences Lawyer’s Guide to Patent Term Adjustment and Patent Term Extensions

December 13th, 2010
in Intellectual Property, Pharmaceuticals / Biotech / Life Sciences |

Upcoming Conference: Full agenda available

Wednesday, January 26 to Thursday, January 27, 2011
Downtown Conference Center, New York, NY, United States

Your Most Pressing PTA/PTE Quandaries –SOLVED!

PTA and PTE are essential to patent life cycle longevity – especially in the life sciences. The life sciences industries invest numerous resources into preserving the patent life and subsequent profits of products which take years to produce. Each day of patent life equals millions of dollars in profi ts. A loss of even one day can have substantial impact on your company’s profi t margin. Moreover, recent court decisions and the introduction of an abbreviated pathway for follow-on biological products have made knowing the “ins and outs” of PTE and PTA a critical competency for every patent practitioner servicing the pharmaceutical, biotechnology and medical device industries.

Learn from the PTA and PTE Masters.
Hear directly from lawyers at the forefront
of Wyeth and Japan Tobacco.
Fine tune your PTE know-how.

ACI has designed this two day intensive program to help you master the skills you need to face your greatest PTA and PTE challenges head on. A faculty of PTA and PTE experts will offer practical solutions and in-depth instruction for everything from eligibility requirements to calculation to the application and reconsideration processes to the interplay of these mechanisms.

Legal Conferences from American Conference Institute

ACI’s Hatch Waxman Series 5th Anniversary Edition

December 9th, 2010
in Hatch-Waxman, Pharmaceuticals / Biotech / Life Sciences |

Paragraph IV Disputes
Expert Insights on Hatch-Waxman Litigation Strategies for Brand Names and Generics
New York City – May 3-4, 2011

Workshop A: May 2, 2011 – Hatch-Waxman and BPCIA 101 – A Primer on IP Basics and Regulatory Fundamentals

Workshop B: May 5, 2011 – Settling Paragraph IV Disputes: Drafting and Negotiating Strategies for Brand-Names and Generics – A Hands-On, Practical Approach

Featuring:

Judicial Insights from:

Honorable Garrett E. Brown, U.S.D.J.
Chief Judge, United States Federal District Court
District of New Jersey
(Trenton, NJ)

Honorable Joel A. Pisano, U.S.D.J.
United States Federal District Court
District of New Jersey
(Trenton, NJ)

Honorable Tonianne Bongiovanni, U.S.M.J.
United States Federal District Court
District of New Jersey
(Trenton, NJ)

FTC Enforcement Insights from:
Markus H. Meier
Assistant Director of the Health Care Division
Bureau of Competition
Federal Trade Commission
(Washington, DC)

Litigation Insights from leading in-house and law firm counsel for brand-name and generic drug companies on:

  • The “ins and outs” and intricacies of every facet of Paragraph IV litigation from pre-litigation concerns through commencement of suit through final adjudication
  • New standards and controversies in double patenting-type obviousness vis- à-vis Sun v. Lilly
  • The impact of inducement actions on Hatch-Waxman litigation
  • New  considerations for damages quantification in view of Plavix
  • A possible shift in inequitable conduct standards due to Therasense
  • The effect of biosimilars legislation on the small molecule patent cliff and the future of Paragraph IV disputes

Reserve your place now at the early bird rate of $1795 by registering before December 31st. Just mention discount code “DECEMBER” and priority service code 975271 when registering.

More information is available here

The FCPA and Mergers and Acquisitions

December 8th, 2010
in Anti-Corruption / FCPA, Expert Guest Blog Entries |

In a webinar on December 2, 2010, Michael Volkov, partner in the law firm of Mayer Brown and Ryan Morgan, Sales and Alliance Director of World Compliance, discussed the implications of the Foreign Corrupt Practices Act (FCPA) to mergers and acquisition.

They advise that businesses which seek to minimize their FCPA liability risks should pay careful attention to the potential exposure created by merger and acquisition activity. This is due to the fact that unwary companies can “purchase” FCPA liabilities by failing to conduct appropriate due diligence of their intended transaction partner. On the other hand, companies alert to those risks have been able to avoid successor liability altogether or, more frequently, obtain assurance about the scope of potential FCPA liability before the transaction is complete. Indeed, successor liability may attach in a stock transfer or merger because the assets and liabilities of the target company generally transfer to the acquiring company after closing; or the liability may attach in an asset purchase depending on the extent of the purchase and whether the target business is continuing or if the purchase agreement specifies which assets and liabilities transfer.

There are several recent examples where companies, which acquired targets, sustained large FCPA fines for the FCPA violations the acquired companies had engaged in prior to the acquisition. These include the Alliance One matter resolved this past summer with a $4.2 million fine for pre-acquisition conduct and $10 million in profit disgorgement. There was also the $240 million fine levied against Saipem for conduct of an acquired subsidiary of ENI, Snamprogetti, where the conduct at issue occurred over 2 years prior to the acquisition. One of the strongest examples is that of eLandia International Inc., which acquired Latin Node Inc., in 2007. Thereafter, it discovered potential FCPA violations, which it self-reported to the DOJ. As reported in the FCPA Blog, in addition to a $2 million fine, eLandia also disclosed that its purchase price for Latin Node “was approximately $20.6 million in excess of the fair value of the net assets” mostly due to the cost of the FCPA investigation, the resulting fines and penalties to which it may be subject, the termination of Latin Node’s senior management and the resultant loss of business. eLandia eventually wrote off the entire investment by placing Latin Node into bankruptcy and shuttering the acquisition.

Volkov advocated beginning with a risk based assessment to focus the required due diligence. Such an assessment would focus on several inquires, these would include such areas as to what countries does the target company operate in and how they rank on Transparency International’s Corruption Index, including the level of corruption in each country? An inquiry into the targets business is also critical, for example does the target company sell to foreign governments and does its business depend on licenses or other approvals from foreign governments? A thorough investigation should include whether relationships exist among target company personnel and government officials through family and friends, etc.

After this more general business risk assessment, the review should turn to the policies and procedures of the target company. Basic inquires such as does the target have a FCPA compliance policy and how well does it maintain compliance records are a good starting point. Does the company have a hotline and does it conduct FCPA training? A critical inquiry is the use of third parties as foreign business representatives. Lastly is the target company or any of its competitors, suspected or under investigation for corruption and are there any other internal investigations ongoing which should be reviewed?

Volkov also noted that after the due diligence is completed, and if the transaction moves forward, the acquiring company should attempt to protect itself through the most robust contract provisions that it can obtain, these would include indemnification against possible FCPA violations, including both payment of all investigative costs and any assessed penalties. An acquiring company should also include reps and warranties that the entire target company uses for participation in transactions as permitted under local law; there is an absence of government owners in company; and that the target company has made no corrupt payments to foreign officials. Lastly, there must be a rep that all the books and records presented to the acquiring company for review were complete and accurate.

The clear trend in FCPA enforcement is an increased and aggressive level of enforcement activity under the both the DOJ and Securities and Exchange Commission. Businesses must be particularly heedful in the engaging in the mergers and acquisitions process, whether acquiring other companies or being acquired. Due diligence in these situations is critical and must encompass the full range of FCPA compliance issues. This article has provided to you a starting point for your analysis.

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 advisor. 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 gives his permission to link, post, distribute, or reference this article for any lawful purpose, provided attribution is made to the author. The author can be reached at tfox@tfoxlaw.com.

© Thomas R. Fox, 2010

EMPLOYMENT DISCRIMINATION LITIGATION

December 8th, 2010
in Litigation |

Here are some of the conference highlights:

  • To date, more than 50 law firms are already participating in this event. With all that’s at stake and with all those who are going to be there, you will miss out if you or your firm does not attend!
  • On the faculty alone there are 13 in-house counsel, including from * Bell Helicopter * Boehringer Ingelheim * Covidien *  FedEx * Clorox *  Prudential * Roche *Qwest * Shell Oil * McDonald’s * Toyota * Trans States *Wellpoint *
  • 8 federal judges  on the faculty, from district courts located in 10 circuits
  • Topics include:

    • FMLA, ADA, and pregnancy claims and the “Bermuda Triangle crossover”
    • retaliation claims
    • age discrimination claims under ADEA
    • gender/sex discrimination
    • 2010 update on Federal and state enforcement activity
    • sexual harassment claims
    • evidence, including “Me Too,” mixed motive, witness credibility and turnover
    • removal and summary judgment
    • mediation and arbitration
    • class actions
    • jury communication and advocacy
    • plus much more

    Drug and Medical Device Litigation

    December 7th, 2010
    in Litigation, Pharmaceuticals / Biotech / Life Sciences |

    ACI’s Drug and Medical Device Litigation conference returns next week for a special 15th Anniversary edition. Join your peers in New York City this holiday season, and learn new strategies from an unprecedented group of industry leaders.

    Reasons you don’t want to miss this year’s program:

    • Practitioners are coming from 34 states
    • In-house participants, including experts from Merck, Eli Lilly, Pfizer, Zimmer, Medtronic, Cephalon, and Bayer
    • FDA and Judicial Keynote Addresses
    • Judicial panel with senior MDL judges
    • Two networking cocktail receptions and luncheons
    • Special networking groups facilitated by in-h
    • ouse counsel

    Transmission Planning Summit

    December 7th, 2010
    in Telecoms & Technology |

    ACI’s inaugural Transmission Planning Summit has been uniquely tailored to provide energy generation, transmission and distribution professionals with the knowledge and tools needed to successfully deploy future, much needed transmission projects within the United States. Senior transmission executives will gather and address the strategic, regulatory, investment and technology issues facing the industry and explore strategies for maximizing the true value of their business.

    This is your opportunity to hear key first-hand perspectives on funding billion-dollar projects, while mitigating risk. Learn from the successes and mistakes of others. Addressing fundamental challenges such as interconnecting variable energy resources, planning, siting, cost allocations, efficiency and system upgrades could prove vital for the successes of your organization.

    • Addressing the challenges of inter and intra-state transmission planning
    • Best practices for obtaining approval for new transmission routes
    • Real-life case studies on ongoing renewable integration projects
    • Understanding the next phase in transmission policy and regulation from FERC
    • Investment and cost recovery opportunities within new transmission planning
    • FERC’s role in cost allocation
    • Examining unique aspects of transmission financing
    • Overcoming construction and risk mitigation issues surrounding future transmission infrastructures
    • Incorporating high-voltage transmission lines to expedite the integration of renewable power
    • Assessing energy storage of renewable technologies and the impact on transmission

    Drug and Medical Device Litigation

    December 7th, 2010
    in Pharmaceuticals / Biotech / Life Sciences |

    Join your fellow industry litigators as ACI’s Drug and Medical Device Litigation conference returns in December for a special 15th Anniversary edition. Join hundreds of your peers in New York City this holiday season, and learn new strategies from an unprecedented group of industry leaders .

    Unique reasons you don’t want to miss this year’s special program:

    • Practitioners are coming from 34 states
    • In-house participants, including experts from Merck, Pfizer, Zimmer, Medtronic, Cephalon, and Bayer
    • Special networking groups facilitated by in-house counsel
    • FDA Keynote Address will be delivered by Ralph Tyler, FDA Chief Counsel
    • Judicial Keynote Address by the Hon. John Heyburn II, Chairman U.S. JPML
    • Further expand your network by attending the two cocktail receptions and networking luncheons

    Drug and Medical Device Litigation

    December 7th, 2010
    in Litigation |

    The indictment of a former associate general counsel for a major pharmaceutical company highlights the heightened government interest in uncovering instances of alleged obstruction of justice and the submissions of false statements to the FDA. At ACI’s 15th Annual Drug and Medical Device Litigation, the event that industry litigators attend to shape future defense strategies, experts will address how to synchronize civil litigation and concurrent government inquiries and minimize the negative impact at trial of a government enforcement action.

    A special focus session will provide expert guidance on surmounting the extra challenges when a government inquiry threatens to impact a products liability case. The panel of experts includes Lisa Dykstra (Morgan Lewis & Bockius LLP), Christopher Gaenzle (Pfizer), Lauren Freeman-Bosworth (Merck) and Daniel Ring (Mayer Brown LLP). They will share their unique insights for how the industry should handle cases where courts and juries can be influenced by assertions of sales misconduct and other practices.

    Our faculty of experts will guide you on ways to:

    • Identify the risks presented to your client by a concurrent government inquiry
    • Control the flow of information between the cases
    • Develop a master strategy and assign counsel to different roles
    • Exclude matters relating to the investigation from the product liability trial

    Drug Patents Expiring During the Next Two Years

    December 7th, 2010
    in Hatch-Waxman, Intellectual Property, Pharmaceuticals / Biotech / Life Sciences, Regulatory & Compliance |

    Excerpt from Pharmalive.com

    NEWTOWN, Dec. 3, 2010–With an abundance of pharma products going off patent during the next several years, M&As – like that between Pfizer and Wyeth – and joint ventures have become increasingly more common as companies seek to replace revenue loss associated with the impending patent cliff for their blockbuster products. Another primary strategy being employed is extending patent life through new dose ranges, unique methods of administration, and/or gaining approvals for new indications.

    Patent-infringement litigation against generic drug manufacturers remains commonplace as branded drug manufacturers struggle to prevent rapid and severe loss of revenue associated with generic entry. However, some of these lawsuits are more often being settled using reverse payments known as “pay-for-delay” deals in which the generic company will agree not to launch a generic drug for a certain period of time in exchange for financial compensation from the innovator company. The Federal Trade Commission reports that these types of settlements cost American consumers $3.5 billion per year as they miss out on generic drug pricing that can be as much as 90% less than brand prices. In early July 2010, the U.S. House of Representatives approved a ban on patent agreements between brand-name and generic drug companies.
    Get the full article at PharmaLive

    Learn more on ParagraphIV with American Conference Institute. Now in its fifth year, ACI’s Paragraph IV Disputes conference has become the most trusted source for the ‘ins and outs’ of Paragraph IV litigation. This first and original conference of its kind serves as the litigation playbook for brand name and generic drug companies in the high-stakes arena of Hatch-Waxman litigation. The inherent intensity of Paragraph IV litigation has been magnified of late by the seemingly unending repercussions of the Hatch-Waxman reforms of the MMA, pending Patent Reform legislation, the approval of an abbreviated pathway for follow-on biological products and the threat of proposed legislation, which may make settlements of these matters near impossible — let alone illegal. These factors have all added to the complexity of this litigation, and have also raised the monetary ante to unprecedented heights. In this environment, it is imperative that brand name and generic pharmaceutical companies and their counsel, have the offensive moves and defensive plays that they need to meet the challenges of pharmaceutical patent endgame litigation.

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