Tags: Corporate Structure, expert, office hours, stock, techsandbox
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On September 17, MBBP Attorney Daniele Ouellette Levy will host Office Hours at TechSandBox on Stock and Corporate Structure. Office Hours provides access to experts in topics such as intellectual property, business formation, benefits, taxes, marketing, sales, funding, IT and technology commercialization. Daniele will be available for one-on-one, 45 minute sessions from 9:00AM- 3:00PM. This event will be offered probono for TechSandBox members and to non-members as space allows.
Slots are already filling! Sign up for Office Hours
Tags: CIO, consumer privacy, data breach, data privacy, Data Security, regulations
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Consumer privacy is emerging into a big headache for companies — and the CIO is bearing the brunt. Most companies analyze customer data in some way, and there are increasing amounts of legislation around how such data handling should be performed. Breaking the rules can land a company in hot water — and leave the CIO out of a job. Sensitive information is often copied from system to system by staff with little understanding of privacy issues and risks surrounding sensitive data. As a result, it falls to the CIO to make sure that a customer privacy strategy is in place. To properly ensure consumer privacy, the CIO should make sure their company is complying with existing regulations, but also be prepared for possible data breaches.
To read the full article
Understanding the rapidly changing landscape of privacy and data security laws is critical for any business. For more information on how MBBP counsels clients in this area, visit our Privacy & Data Security practice or check out our related resources.
Tags: Intellectual Property, patent application, patents
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Don’t be fooled by the ads you see promoting the quick filing of a patent application. MBBP’s Lisa Warren gives some insight on why it is important to communicate with a patent attorney when filing a patent application. By considering your invention and preparing the right questions before contacting an attorney, you’ll be sure to save valuable time and money. Are you fully prepared to file for your patent?
For more information on this topic, please contact Lisa Warren.
MBBP Client Acquired by Blackboard 08/19/2014Posted by Morse, Barnes-Brown Pendleton in Attorney News, Client News, Computer Software & Hardware, MBBP news.
Tags: blackboard, campus card services, cardsmith, mbbp, security solutions, technology
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MBBP client CardSmith, the industry’s leading cloud provider of campus card solutions and turn-key card program management services, has been acquired by Blackboard, the world’s leading education technology company. Blackboard offers campus card services and integrated campus commerce and security solutions to hundreds of institutions. CardSmith joins Blackboard’s growing set of student identification services and will broaden the credentialing deployment options the company offers to schools and institutions.
For the full press release, please visit Blackboard’s website
MBBP Attorney Helps Fight Cancer: PMC 2014 08/19/2014Posted by Morse, Barnes-Brown Pendleton in Attorney News, Life Sciences, MBBP news, Nonprofit.
Tags: Cancer Research, Dana-Farber, Pan Mass Challenge, PMC, The Jimmy Fund
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This year, MBBP Partner Mike Cavaretta completed his tenth Pan Mass Challenge. The PMC is a two-day 194-mile bike ride across Massachusetts from Sturbridge to Provincetown to raise money for The Dana-Farber Cancer Institute.
“Why do I do it? Some people might say it’s because I’m crazy. Others might say it’s for the free beer (Harpoon!). And still others might say it’s for the challenge and the camaraderie. They’d all be right. But the main reason I do it is to help wipe out cancer”
The Pan Mass Challenge has raised more money for charity than any other event in the country. Their goal this year is to raise $40 million dollars by October 2014, 100% of which will go to Dana-Farber and the Jimmy Fund. To donate on Mike’s (or other riders’) behalf please visit the PMC website.
Congrats, Mike! Well done!
Tags: biologics, biosimilar, BPCI Act, celltrion, FDA, infliximab, remsima, Sandoz
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On August 8, 2011, Celltrion announced that it filed a biosimilar application under the Biologics Price Competition and Innovation Act (BPCI Act) for its infliximab biosimilar. Celltrion’s infliximab biosimlar is already marked in over 50 countries worldwide, including Europe, Canada and Japan, under the brand name of Remsima®. Celltrion’s announcement comes shortly after Sandoz’s recent announcement that the FDA had accepted its application for a filgrastim biosimilar application, and marks the second biosimilar application known to be filed under the BPCI Act, as well as the first application for a biosimilar mAb.
Tags: Amgen, biosimilars, FDA, FDA Week, insiderhealthpolicy.com, patent, Sandoz
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On August 8th InsiderHealthPolicy.com’s FDA Week, an exclusive weekly report on Food and Drug Administration Policy, regulation and enforcement, published an article titled “Biosimilar ‘Patent Dance,’ Litigation Could Coincide With Possible Approval”. The article discusses the FDA’s recent acceptance of the first biosimilar application from Sandoz for a biosimilar filgrastim, a version of Amgen’s Neupogen. This acceptance of Sandoz’s application has also set off a series of deadlines outlined in statute that will determine which patents the two companies will litigate. MBBP Patent Attorney David Fazzolare was quoted in the article discussing the patent exchange process including several other deadlines before possibly resulting in litigation. David stated:
The earliest that I see anything publicly happening, absent any press releases from Sandoz and Amgen, is March of next year.
The same two companies are currently engaged in litigation over patents related to a different product, Enbrel, which is currently on appeal in the U.S. Court of Appeals for the Federal Circuit and oral arguments are slated for Sept. 10.
For more information on this topic, please contact David Fazzolare.
Tags: application, biologic, Biologics Price Competition and Innovation Act, biosimilars, BPCI Act, drugmakers, FDA, PHS Act
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On August 4, 2014, the Food & Drug Administration (FDA) released its latest guidance in a series of guidance documents issued as part of its ongoing effort toward implementing a biosimilar approval pathway under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). In contrast to previously released guidance which dealt with the scientific and regulatory considerations involved in reviewing biosimilar applications, such as the clinical pharmacology data required to demonstrate biosimilarity to a licensed biologic, this latest guidance outlines the FDA’s current thinking with respect to determining whether a licensed biologic is entitled to the exclusivity provided for in Section 351(k)(7)(C) of the Public Health Service Act (PHS Act), as amended by the BPCI Act.
To spur the development of innovative and lifesaving biologic medicines, the BPCI Act amended the PHS Act to award periods of exclusivity to certain licensed biologics during which the FDA is prohibited from taking certain actions with respect to an application for a biosimilar version of those licensed biologics. The Act provides two relevant exclusivity periods which are both calculated from the date on which a licensed biologic was first licensed. The guidance refers to this date as the date of “first licensure.” Section 351(k)(7)(C) provides that licensure of an application for a biosimilar or interchangeable product under the BPCI Act may not be made effective until 12 years after, or submitted to the FDA for review until 4 years after, the date of first licensure of the licensed biologic referenced in the biosimilar application. Thus, establishing the date a licensed biologic was first licensed is critical to determining when the licensed biologic’s exclusivity ends and thus when biosimilar and interchangeable products may enter the market.
Typically, the date of first licensure is the initial date a given biologic product is licensed under 351(a). Not every licensure of a biological product under 351(a), however, is considered a “first licensure” that gives rise to its own exclusivity period. To assist stakeholders and reviewers at the FDA in determining whether licensure of a biologic product under 351(a) gives rise to its own exclusivity period, the guidance outlines circumstances in which a licensure would not be considered a “first licensure.” For example, the date of first licensure does not include the date of licensure for a supplement for the biological product that is the reference product, or a subsequent application by a biologic manufacturer or sponsor (or related entity) for a change to a licensed biologic that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength, or a modification to the structure of the biological product that does not result in a change in safety, purity, or potency. In other words, for the date of licensure of a modified version of a biologic licensed under 351(a) to be considered the date of first licensure, there must be a modification to the structure of the biologic that results in a change in safety, purity, or potency.
The guidance notes that the FDA intends to determine on a case-by-case basis, based on data submitted by the sponsor, whether a structural modification to a licensed biologic results in a change in safety, purity, or potency that is sufficient to trigger its own exclusivity period. However, the guidance does not elaborate on how significant those changes must be for the modified biologic to obtain its own exclusivity period. In this manner, the guidance falls short of providing much needed certainty on the topic. It is important to remember, however, the guidance has not yet been finalized by the FDA and is subject to change. Moreover, in releasing the guidance that the FDA passed another major milestone toward implementing the biosimilar approval pathway created by the BPCI Act and shed some light on the topic of biologic exclusivity.
OYO Sportstoys Featured on WBZ-TV 08/04/2014Posted by Morse, Barnes-Brown Pendleton in Client News, Licensing & Strategic Alliances.
Tags: acton, kinex, LEGO, licensing, mega blocks, MLB, NBA, NFL, NHL, oyo, OYO sportstoys
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MBBP client OYO Sportstoys, Inc. was recently featured on a segment of WBZ-TV discussing its factory in Acton, Massachusetts that is creating mini sports figures of famous athletes. OYO has licensing agreements with MLB, the NFL and the NHL which allows them to use the names of all players. They hope to get a deal with the NBA soon as well. OYO figures are compatible with other notable building block toys like Lego, Kinex, Mega Blocks and more. Each little OYO mini-figure is customized to look like the real player and gets a little water bottle and a football, baseball or hockey stick.
Check out the full video here: Acton Company Doing Big Business Making Little Plastic People
Tags: Coca-Cola, false advertising, ip, lanham act, lexmark international, POM wonderful, static control components, supreme court, trademark, unfair competition
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On August 12th MBBP is hosting a seminar on Unfair Competition/False Advertising: How the Supreme Court’s recent decisions impact false advertising claims against competitors. The Supreme Court recently issued two decisions, Lexmark International, Inc. v. Static Control Components, Inc. and POM Wonderful LLC v. Coca-Cola Co., which impact rights a party may have against competitors for false advertising claims under the Lanham Act. This seminar, presented by MBBP Trademark Attorney Sheri Mason, will discuss unfair competition and false advertising under the Lanham Act, the Lexmark International, Inc. v. Static Control Components, Inc.and POM Wonderful LLC v. Coca-Cola Co. decisions, and how these decisions may affect your rights against third parties.
To learn more or to register, please visit our events page.
For more information on false advertising, please feel free to contact Sheri directly.
Tags: cease and desist, consulting agreement, natural blue, privately-held, public companies, SEC, shareholders
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By: Mark Tarallo
On July 16, 2014, the United States Securities and Exchange Commission (“SEC”) brought an action against Natural Blue Resources, Inc. (“Natural Blue”), James E. Cohen (“Cohen”) and Joseph A. Corazzi (“Corazzi”)(Natural Blue, Cohen and Corazzi are referred to collectively as the “Respondents”). The SEC is seeking a cease-and-desist order against the Respondents, alleging among other items that Cohen and Corazzi acted as the de facto executive management of Natural Blue, while failing to make any of the disclosures required of executive officers of a public company.
Natural Blue was a privately-held corporation based in Nevada that went public in August, 2009 via a reverse merger with Datameg Corporation. In November 2009, Natural Blue entered into a consulting agreement with JEC Corp. (“JEC”) a corporation owned by Cohen’s family. Cohen was the President of JEC, and Corazzi was employed by JEC. Cohen and Corazzi each had extensive disciplinary histories that would have prevented them from serving as an executive officer of Natural Blue.
From the time that Natural Blue went public in 2009 through the end of 2011, Cohen and Corazzi exercised a significant degree of control over Natural Blue through JEC. They recommended virtually all of the directors that served on the board of Natural Blue, and almost all of the key executive positions were filled by individuals with whom they had significant preexisting business or social relationships. Despite the fact that Natural Blue had a named CEO, Cohen and Corazzi controlled all of the key functions of Natural Blue, such as the accounting department (the CFO was an associate of Cohen’s with whom Cohen shared outside office space). Cohen and Corazzi dealt directly with third parties and purported to enter into agreements on behalf of Natural Blue. Despite the fact that the actions of Cohen and Corazzi did not actually generate any revenue for Natural Blue or its shareholders, they were paid significant amounts of cash and Natural Blue stock (which was sold at a profit) for their efforts.
The SEC’s action alleges among other things that the Respondents engaged in fraud by failing to accurately report the roles played by Cohen and Corazzi, and that those failures caused harm to investors. Given the disciplinary histories of Cohen and Corazzi, it is clear why they went to the lengths that they did to hide their actual roles. The SEC filing can be found here.
For more information on this topic, please feel free to contact Mark Tarallo.
Biosimilars Developers Watch Closely as FDA Accepts First Biosimilar Application from Sandoz 07/29/2014Posted by Morse, Barnes-Brown Pendleton in Intellectual Property, Life Sciences.
Tags: application, biologic, biosimilars, drugmakers, FDA, filgrastim, neupogen, Sandoz
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Sandoz, a Novartis Group company, announced on July 24, 2014 that the US Food and Drug Administration (FDA) has accepted for review its application for a biosimilar version of filgrastim. The reference product, Neupogen®, which brought maker Amgen Inc. $1.4 billion in sales in 2013, is a biologic used to prevent
infections in cancer patients getting certain treatments that result in a decrease in infection-fighting white blood cells. Sandoz’s application for filgrastim is the first biosimilar application known to have been accepted by the FDA for review since the Biologics Price Competition and Innovation Act (BPCIA) established an approval pathway for biosimilars in 2009. Sandoz’s biosimilar filgrastim has already been approved in more than 40 countries outside the US under the brand name Zarzio®, including in Japan and Europe, and could be the first biosimilar approved in the US under the BPCIA. Such biosimilars could offer patients more affordable alternatives to existing biologic medicines similar to the way that generic drugs approved under the Hatch Waxman Act offer patients more affordable alternatives to their brand-name counterparts.
Sandoz’s announcement came shortly after the FDA released its draft guidance for industry entitled “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.” The FDA had previously released three draft guidance documents outlining the FDA’s then-current thinking on important scientific and regulatory considerations relevant to submitting biosimilar applications, however, none of the industry guidance documents have yet been finalized. More importantly, none of the guidance documents provide clarity on the evidentiary thresholds required by the FDA to obtain interchangeability status for a biosimilar, which is required before an approved biosimilar can be substituted for a prescribed biologic without first consulting the prescribing physician. Although it is unclear whether Sandoz is pursuing interchangeability status for its biosimilar version of fligrastim, the FDA’s review of Sandoz’s application could provide much needed clarity on this as well as other issues related to the approval pathway for biosimilars. As the FDA weighs approval of Sandoz’s application, drugmakers are certain to gain insights on how the FDA will review future biosimilar applications.
Tags: employees, minimum wage, non-tipped, tipped, wage act, wage and hour
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On June 26, 2014, Governor Deval Patrick signed a bill into law which will raise the hourly minimum wage in Massachusetts for the first time since 2008. As a result of these increases, Massachusetts’ minimum wage will be amongst the highest in the country. Employers who fail to comply with the minimum wage increase will be in violation of the Massachusetts “Payment of Wages” statute and be subject to mandatory treble (triple) damages, attorney’s fees, and possible criminal penalties.
To learn how and when the minimum wage will change, or why you should comply, please see our full Wage & Hour Tip of the Month.
Please feel free to contact MBBP’s Employment Law Group with any questions.
Tags: amateur sleuths, boston globe, cold case, deborah halber, the skeleton crew
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Congratulations to MBBP client Deborah Halber on the publication of her first book, The Skeleton Crew: How Amateur Sleuths are Solving America’s Coldest Cases (Simon & Schuster, 2014)! Publishers Weekly calls this “A lively study that’s … eminently entertaining and will be devoured by armchair detectives.” The Boston Globe says that Deborah writes “vividly and engagingly” and calls the book “captivating.” We say “Way to go, Deborah!”
Should You Incorporate Your Business? 07/23/2014Posted by Morse, Barnes-Brown Pendleton in Venture Capital & Private Equity.
Tags: business structure, corporation, entities, incorporation, llc, llp, sole proprietorship, state filings
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By: Hillary Peterson
70% of all businesses in the country are organized as a sole proprietorship, but operating a business as an unincorporated entity is not without its disadvantages. Because of this, it is important for any business owner to consider forming a separate legal entity, such as a corporation, limited liability company or partnership, regardless of the size or nature of the business. There are a number of significant benefits to forming a corporation or LLC, including:
- Protection of Personal Assets
- Ability to Raise Capital
- Perpetual Existence
- Flexible Tax Treatment
- Additional Credibility
Learn more here.
Tags: biological products, biosimilar, FDA, pharmacist, vaccines, viruses
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By: Stanley Chalvire
Massachusetts recently enacted Chapter 143 of the Acts of 2014, entitled “An Act relative to the substitution of interchangeable biosimilars,” authorizing pharmacists to fill prescriptions that are written for brand name biological products with the corresponding and generally less expensive biosimilar product. A biosimilar is a biological medicine that the U.S. Food and Drug Administration (FDA) has determined is highly similar to an FDA-approved biological product, notwithstanding minor differences in inactive components, for which there are no clinically meaningful differences between such biosimilar product and the reference biological product in terms of safety, purity and potency.
The Act defines “biological product” to include, for example, viruses, vaccines, blood components or derivatives and certain proteins that are applicable to the prevention, treatment or cure of a disease or condition of human beings. An “interchangeable prescription biological product” is defined as a biosimilar that has been determined by the FDA to be substitutable with the prescribed reference biological product.
The Act generally tracks existing Massachusetts laws governing the substitution of generic drugs for prescribed brand name drugs. In particular, the Act provides that:
- A pharmacist filling a prescription for a biological product prescribed by its trade or brand name may substitute an interchangeable biological product;
- The prescriber can instruct against substitution of an interchangeable biological product on a patient-specific basis;
- The dispensing pharmacist or the pharmacist’s designee must notify the prescribing practitioner and the patient of the substitution;
- The dispensing pharmacist or the pharmacist’s designee, the prescribing provider and administering practitioner shall retain a record of each substitution, for not less than 1 year from the date of the last entry in the profile record; and
- In the event of noncompliance by a pharmacist or a practitioner, the purchaser or patient may inform the director of consumer affairs and business regulation of such noncompliance.
The FDA has yet to approve a biosimilar product, much less an interchangeable biosimilar product which pharmacists in Massachusetts would be permitted to substitute under the Act. Massachusetts now joins Florida, North Dakota, Oregon, Utah, Virginia and Indiana on the forefront of states enacting laws governing the substitution of biosimilars.
For more information on the Act or biosimilars, please contact Stan Chalvire.
Upcoming Seminars in Waltham & Cambridge! 07/16/2014Posted by Morse, Barnes-Brown Pendleton in Corporate, Employment, Events, Intellectual Property, Legal Developments, MBBP news, Privacy and Data Security.
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The end of Summer and beginning of Fall are the perfect time to get back into the swing of things! Join us for timely, informative seminars on False Advertising, Sweepstakes & Contests, and Employment Law. Get the details below.
LIMITED SEATING – REGISTER TODAY!
8/12/14 – Unfair Competition / False Advertising: How the Supreme Court’s recent decisions impact false advertising claims against competitors. (Waltham, MA) – In this seminar, we will discuss unfair competition and false advertising under the Lanham Act, the Lexmark International, Inc. v. Static Control Components, Inc.and POM Wonderful LLC v. Coca-Cola Co. decisions, and how these decisions may affect your rights against third parties. Complimentary seminar!
9/18/14 – Playing a Game of Chance: Understanding the Differences Between Sweepstakes, Contests and Illegal Lotteries. (Cambridge, MA) – Sweepstakes and contests are a great way to promote your business. However, there is a fine line between conducting legal sweepstakes or contests and conducting an illegal lottery. In this seminar, we will discuss what constitutes an illegal lottery, ways to structure contests / sweepstakes to comply with federal & state laws, state registration requirements and penalties for conducting an illegal lottery. Complimentary seminar!
10/17/14 – The Morse Course: Employment Law Compliance & Risk Prevention for Managers, Supervisors and HR Professionals. (Waltham, MA) – Learn practical information and valuable strategies for avoiding the many traps that lead to expensive and time-consuming HR problems and employment litigation. Group discount available!
SEC Chair Speaks on Corporate Governance 07/10/2014Posted by Morse, Barnes-Brown Pendleton in Public Companies.
Tags: advisory, attitudinal, corporate governance, directors, gatekeepers, SEC, self-reporting
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By: Mark Tarallo
On June 23, 2014, SEC Chair Mary Jo White spoke to the Twentieth Annual Stanford Directors’ College held at the Stanford University Rock Center for Corporate Governance. Chair White’s remarks focused on the SEC’s view of the role of the board of directors in a corporation.
Chair White characterized her remarks as covering three topics-one attitudinal, one advisory, and one descriptive. The “attitudinal” topic was the view that the SEC takes regarding directors as the most important “gatekeepers” of a corporation. She noted that “it is essential for directors to establish expectations for senior management and the company as a whole, and exercise appropriate oversight to ensure that those expectations are met. It is up to directors, along with senior management under the purview of the board, to set the all-important “tone at the top” for the entire company.” From an advisory perspective, Chair White spoke to the obligation of the board to engage in self-reporting when they learn of any wrongdoing and working cooperatively with regulators. She referred to prior decisions and press releases to show how self-reporting and cooperation is viewed favorably by the SEC, and called on directors to “[m]ake it clear from the outset that the board’s expectation is that any internal investigation will search for misconduct wherever and however high up it occurred; that the company will act promptly and report real-time to the Enforcement staff on any misconduct uncovered; and that the company will hold its responsible employees to account.” Last, Chair White described the workings of the SEC’s Whistleblower program and why it is necessary for the board to take any tips or accusations seriously. It is clear from her remarks that the SEC plans to hold boards accountable for compliance failures, and while her remarks were targeted at public reporting companies, they are instructive for private companies as well, and directors of private companies should take note of the increasing obligations to ensure compliance.
A full copy of the text of Chair White’s comments can be found here.
Please feel free to contact Mark with any questions on this topic.
Tags: british open, clorox, dean foods, garelick farms, insider trading, land o lakes, non-public information, phil mickelson, publicly-traded
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By: Joseph Marrow
As Phil Mickelson prepares to play in the upcoming British Open, he faces additional insider trading allegations (there were previous reports that Mickelson profited from trades involving Clorox, but that investigation allegedly ended without any action). Most recently, federal authorities subpoenaed Dean Foods (Land O Lakes, Garelick Farms and TruMoo brands), a publicly-traded company, about trading activity that closely preceded the announcement of a subsidiary spinoff. Prior to the spinoff, Mickelson and William Walters, a sports gambler and friend of the golfer, placed trades in the shares of Dean Foods. Allegedly, Walters made $15 million in profit and Mickelson made $1 million in profit from the trades. According to reports, the investigation has focused on whether someone inside Dean Foods tipped Walters with material non-public information regarding the proposed spinoff and whether Walters then informed Mickelson.
Insider trading refers to the practice of profiting from the buying and selling of stock in publicly-traded companies through the use of non-public information. In addition, an individual can trip up the insider trading rules by being the “tippee” (recipient) of inside information from a “tipper” (person with access to the inside information). This is the situation purportedly facing Mickelson. Proving insider trading can be very challenging for prosecutors. There has been a noticeable increase in the investigation and prosecution of insider trading cases. Targeting a high profile person like Mickelson may bring more attention to insider trading claims and may serve as a deterrent to individuals considering trading on material non-public information.
For more information on this topic, please feel free to contact Joe.