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Broude P.,Foley and Lardner LLP
Medical Device and Diagnostic Industry | Year: 2010

High valuations and management control are just two reasons for a device company to consider an IPO for its growth plans is discussed. An IPO has historically represented an exit strategy for venture capital funds and other investors. Raising equity in a public offering is generally the least expensive form of capital available to a business, both in terms of the percentage of ownership sold to new investors and the control that must be given up by existing stockholders. The valuation achieved in a public offering can often be 50% higher than could be obtained by selling equity to investors in a private placement, since private investors insist on a significant discount from an estimated IPO or sale price to compensate them for the illiquidity of their investment. Management and existing private investors can use an IPO to achieve liquidity for their investment in the company without giving up control or the benefits of future growth. Going public is not necessarily the right choice for every medical device or life science company that needs to raise capital or create liquidity for its shareholders. Source

Simon D.W.,Foley and Lardner LLP | Holland E.J.,Foley and Lardner | Husisian G.,Foley and Lardner
Medical Device and Diagnostic Industry | Year: 2010

The Foreign Corrupt Practices Act (FCPA) device companies need to establish robust, risk-based compliance programs to monitor their foreign business activities. Many industry executives are surprised to discover that under the broad interpretations of the FCPA adopted by US enforcement agencies, these decision-makers can qualify as foreign officials if the decision-makers' company is owned or controlled by a foreign government. Recent government actions make it clear that medical device and pharmaceutical companies are squarely in the cross hairs of those charged with enforcing the FCPA. Mechanisms should be designed to ensure that the FCPA's policies, standards, and procedures are communicated to all directors, officers, employees, and third parties, including through periodic training and periodic written communications regarding FCPA requirements. The compliance program should include policies, standards, and procedures that allow an organization to respond reasonably to any violations detected, including appropriate investigative procedures and mechanisms. Source

Kramer M.S.,Foley and Lardner LLP
Medical Device and Diagnostic Industry | Year: 2011

The Federal Communications Commission recently proposed a new experimental radio license intended to facilitate development of wireless medical devices. Under the proposed medical program experimental license, qualifying institutions would be permitted through a single FCC authorization to conduct ongoing research and experimentation related to the development of new medical devices that utilize wireless technology. The proposed experimental license was developed in collaboration with FDA and the American Society for Healthcare Engineering. The FCC has proposed that the license have an initial duration of five years and be renewable thereafter. The license would provide wireless device manufacturers and developers who are teamed with licensed institutions the broad ability to test and assess operational readiness of new devices under a single license without obtaining FCC pre-approval. The proposed license, however, is a blanket authorization that would provide the licensee with substantial flexibility in controlling what products are tested and how testing is conducted. Source

Konski A.F.,Foley and Lardner LLP | Wu L.X.,Foley and Lardner LLP
Cold Spring Harbor Perspectives in Medicine | Year: 2015

Ownership of a U.S. patent is based on inventorship. In the United States, an inventor is the owner of the claimed invention unless it is assigned to another entity. The correct naming of inventors is important, and the improper naming of inventors in a patent can be grounds for rendering the patent unenforceable. Each inventor must make an intellectual contribution, solely or jointly, to at least one element of a claim in the patent. This is in contrast to authorship of a research article, where authors may be named to acknowledge contribution to the reported research rather than an intellectual contribution. Thus, identifying inventors for a patent is not the same as identifying authors for a publication. © 2015 Cold Spring Harbor Laboratory Press; all rights reserved. Source

Potts B.H.,Foley and Lardner LLP | Zoppo D.R.,Foley and Lardner LLP
Electricity Journal | Year: 2014

EPA's new proposal to regulate carbon emissions from existing power plants is the most significant step this country has ever taken to address climate change-but is it consistent with the Clean Air Act? An analysis of the three biggest legal questions facing the rule suggests that the agency's legal justifications for the plan are tenuous, and the courts are likely to overturn at least part of the proposal. © 2014 Elsevier Inc. Source

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