How New Trade Secret Legilation Impacts Pharma Compliance Programs

By Laredo & Smith

Two enacted criminal statutes have raised the stakes not only for individuals and corporations that misapporpriate another company’s trade secrets, but also for the companies responsible for safeguarding those trade secrets from theft. For the legal, human resources, and complaince departments of a pharmaceutical company, these statutes create both risks and opportunities and underscore the importance of re-assessing the company’s policies, training and internal controls relating to trade secrets and other proprietary information. This article outlines how taking proactive measures, pharmaceutical companies can leverage the strengthened EEA to improve an often neglected but increasingly important area of compliance that is directly tied to entrerprise risk management.

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This article first appeared in the Pharmaceutical Compliance Monitor, March 2013.

Caronia and the ‘New’ 1st Amendment Safe Harbor

By Laredo & Smith

The Second Circuit decision vacating Alfred Caronia’s criminal misbranding conviction on free speech grounds has been hailed as a landmark First Amendment case and a victory for the pharmaceutical company. Although lawyers and commentators have been arguing since the 1990s that off-label promotion (at least when accurate and non misleading) deserves some constitutional protection under the First Amendment, prior to Caronia efforts to get the issue before the federal courts have come up short. Amendment protection, will the U.S. Food and Drug Administration someday have to consider drafting guidance on a First Amendment safe harbor?

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This article first appeared in the Law 360, December 2012.

Shareholder Duties and Disputes in Closely-Held Corporations in Massachusetts

By Marc C. Laredo

Over thirty years ago, the Supreme Judicial Court issued its landmark ruling in Donahue v. Rodd Electrotype Co. of New England, Inc. in which it established standards for the governance of closely held corporations in Massachusetts and held that each shareholder in a closely-held corporation owes a fiduciary duty to other shareholders. In the years since this decision, courts have analyzed an array of issues involving management and control of closely-held corporations. This article reviews the ruling and then discusses significant developments that followed.

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Agree To Disagree: How To Break Up Without Destroying The Closely-Held Business

By: Marc C. Laredo, Esq. Laredo & Smith, LLP

The break up of a closely-held business, if not properly managed, can have disastrous consequences for all concerned. There is a means, however, for avoiding, or at least tempering, the negative effects of a break up: a well-crafted, written agreement between or among the founders that allows them to each achieve their personal goals while striving either (a) to maintain the business as an existing entity or (b) to dissolve the business in an orderly fashion so that the individual owners can continue to do business, albeit in a different form.

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