Life Sciences

News of Abraham J. Kwon joining Lowenstein Sandler as partner in its Emerging Companies & Venture Capital (ECVC) practice group is reported in Reuters, Financial Times, Bloomberg Law, Politico, and Law360, where Kwon notes that the chance to join the group’s founders, Ed Zimmerman and Raymond P. Thek, as well as his former colleagues Meredith Beuchaw and Brendan J. Koeth, was "too exciting an opportunity to pass up.” He adds: "Lowenstein's VentureCrush platform was another enticement: Both my investor and startup clients will greatly benefit from the opportunities offered by the program to grow their networks and expand their knowledge.” (subscription required to access some articles)

James C. Shehan, Chair of Lowenstein’s FDA Regulatory practice, tells Pharmacy Times that the booming market for weight control drugs like Ozempic and Wegovy is “somewhat remarkable to me, because it was there in plain sight in 2010, and even before that, in the scientific data.”

In part one of a video interview with Pharmacy Times, James C. Shehan, Chair of Lowenstein’s FDA Regulatory practice, discusses the growth of the GLP-1 receptor agonist market for medication-assisted weight loss. Detailing the history of drugs like Ozempic and its long line of predecessors, Shehan explains the market’s rapid expansion and the explosion of investor interest, and considers future competitive and regulatory dynamics. He notes that “this is not a new class of drugs. … The promising trend is the expansion of indication: you're now 14 years in, and there haven't been significant safety issues.”

Law360 notes that the biotech company Zymergen has obtained confirmation of its Chapter 11 plan by a Delaware bankruptcy court after resolving an informal objection asserted on behalf of a class of investors by Lowenstein Sandler’s Bankruptcy & Restructuring Department. The article notes that the plan will not impact the class representative’s right to prosecute the securities litigation on behalf of the class against Zymergen (to the extent of available insurance) and against the non-debtor defendants, who are alleged to have misled investors about issues with Zymergen’s flagship technology.

Michael S. Etkin, Andrew Behlmann, and Michael Papandrea served as bankruptcy counsel to the securities class. (subscription required to access article)

James C. Shehan, senior counsel and Chair of Lowenstein’s FDA Regulatory practice, comments in The Pink Sheet and Generics Bulletin (subscription required to view entire article) on a recent FDA memo explaining its rationale for a decision on when first interchangeable biosimilar exclusivity begins and ends, which could impact future biosimilar and interchangeable product development and sales. Shehan, who previously served as general counsel for a global healthcare company as well as regulatory counsel at the FDA, helped draft some provisions in the Biologics Price Competition and Innovation Act that created the biosimilar pathway, says that the memo addresses a situation that the law does not address, where patent litigation associated with a biosimilar starts and ends before an interchangeability application for the same product is approved, adding: “It’s a complicated fact pattern... where you have to apply some principles to a situation that wasn’t contemplated by Congress.” More importantly, Shehan thinks the agency should have issued formal guidance: “This is a somewhat more obscure way of doing it.”

Jonathan L. Lewis speaks with Law360 about the Federal Trade Commission’s (FTC) settlement with Amgen regarding the latter’s $27.8 billion purchase of Horizon Therapeutics. “The actual significance of the settlement is largely up to the beholder,” Lewis says. “While the companies may describe the agreement as effectively a placebo, it does block the [bundling] conduct the FTC had feared.”

Law360 includes comments by Jonathan L. Lewis in its article on the Department of Justice and the Federal Trade Commissions’ most recent antitrust enforcement cases. Regarding the FTC’s challenge to Amgen Inc.'s proposed billion-dollar purchase of Horizon Therapeutics PLC on the grounds that Amgen's large portfolio of drugs might protect the monopoly positions of some Horizon products by bundling rebates, Lewis says: "That type of theory in merger transactions has found some light involving hospitals." Lewis adds that “this challenge is dependent heavily on timing,” especially in light of Regeneron’s similar claims against Amgen.

Jonathan L. Lewis comments on the impact of the U.S. Federal Trade Commission’s (FTC) suit to block Amgen’s (NASDAQ:AMGN) acquisition of Horizon Therapeutics (NASDAQ:HZNP) in Mergermarket, drawing comparisons to a private lawsuit against Amgen brought recently by Regeneron Pharmaceuticals (NASDAQ:REGN) alleging illegal bundling. “Given more than a year of rhetoric by the agency about the need to address the role of PBMs and other drivers of costs in the pharmaceutical space— including bundling, specifically— parties are cognizant of the elevated risk of intervention,” says Lewis. Dealreporter and Policy and Regulatory Report also carried the story. (subscription required to access articles)

James C. Shehan, chair of Lowenstein’s FDA Regulatory practice, talks with AIS Health about legislative measures currently under consideration regarding pharmacy benefit managers (PBMs) and their role in drug pricing. He says: “It’s one of those things where it’s not a burning issue that you can poll and constituents go crazy about, but the issue of PBMs and what the heck are they — and the feeling that there is something potentially improper about the way they’re doing [their job] — may be enough to get legislation [passed].”

In a second AIS Health article, Shehan notes that PBM-affiliated GPOs “are viewed as more suspect than a group of hospitals getting together to negotiate better prices;” adding: “no one understands what they are and what they do; part of that is because they have tentacles, they have fingers in a lot of pies.” (subscription required to access articles) 

James C. Shehan, chair of Lowenstein’s FDA Regulatory practice, tells Law360 that he believes the impact on the pharmaceutical industry of the Inflation Reduction Act (IRA) allowing Medicare to negotiate prescription drug prices will be limited initially “because negotiation won't start until 2026, and only a small subset of marketed drugs will be affected.” Furthermore, he adds, “new products, orphan drugs and products with generic or biosimilar competition are exempted," and "the price-setting of new drugs is not affected by the IRA.”

Doreen M. Edelman, Chair of Lowenstein’s Global Trade & National Security, talks to Export Compliance Daily about the Bureau of Industry and Security's shift towards more aggressive enforcement policies, noting that she views this as a “recommitment” to cracking down on illegal technology transfers “especially for exports to China and Russia. “

Edelman further notes that an increase in enforcement may persuade more companies to pursue voluntary self-disclosure, which not only helps with “keeping the company out of the news,” but also demonstrates that “this is not a joke, that the government takes this seriously,.” She doubts the Commerce Department will start publishing charging letters immediately: “[Commerce is] always going to keep their discretion. They're not getting rid of the pre-charging letter discussions, so there's still going to be flexibility.” (subscription required to access)

Doreen M. Edelman, Chair of the firm’s Global Trade & National Security practice, stresses the need for companies to screen their client lists against government sanctions databases in light of the sanctions against Russia in CNBC’s “Small Business Playbook.” Edelman says the sanctions add to the reasons start-ups in technology and smaller companies, in general, need to have compliance programs in place, though they are less likely to have developed or updated such programs. “If the last time you screened was three years ago, I’m not sure OFAC will give you much credit,” says Edelman.

In Law360, James C. Shehan, Chair of Lowenstein’s FDA Regulatory group, discusses a ruling by Supreme Court nominee Ketanji Brown Jackson involving the Orphan Drug Act made while she was a judge on the D.C. District Court; Jackson ruled that a drug company did not need to prove its product was clinically superior to a similar approved medicine, despite FDA regulations requiring such a showing. "It was a case where the judge seemed to run counter to the usual deference shown to the expertise of administrative agencies like the FDA," Shehan says. After Jackson’s decision, the FDA responded by stating that the ruling wouldn't stop it from withholding exclusivity for new orphan drugs that were the same as previously approved medications, a move Shehan calls “highly unusual.” Moreover, Congress later passed legislation that included the FDA regulations that Judge Jackson ruled against.

In TIME, Doreen M. Edelman, partner and Chair of Lowenstein’s Global Trade & National Security group, and senior counsel Laura Fraedrich discuss the impact of sanctions on Cuba-based organizations and businesses that have been locked out of online services such as file transfer sites, social media managers, cloud services, development apps, video calling, and education platforms. Edelman explains that the complicated trade restrictions and inconsistent history of U.S.-Cuba relations discourages U.S. companies from finding workarounds for clients located there. She says: “I’ve worked with a lot of clients over the years who take a very conservative approach and decide they don’t want to run that risk. [Startups especially are] not going to want to pay for legal fees for stuff like this, so they’ll just follow the embargo and be done with it.” Fraedrich adds that the U.S. Treasury Department’s Office of Foreign Assets has lately been more “targeted at people who are in or have been in the government; …you really wonder why we couldn’t go to something like that for Cuba to mitigate some of these secondary and tertiary effects.”

In Supply Chain Management Review, Doreen M. Edelman, partner and Chair of Lowenstein’s Global Trade & National Security practice, and Laura Fraedrich address the recent rollback of tariffs on steel and aluminum imports, and the potential impact on supply chain challenges. Edelman advises companies “to stay engaged and hands-on. Make sure paperwork and advanced CBP filings are in order. Contact everyone in the import supply chain to ensure your products are a priority known to all parties in the import chain. Ensure your classifications, markings, and country of origins representations are accurate, complete, and don’t trigger CBP questions.”

Fraedrich says that the lifting of these tariffs “will help U.S. manufacturers be more competitive in the world market while at the same time helping the EU steel and aluminum manufacturers maintain their production. The move also reinforces the Biden Administration’s vow to re-engage our allies in bilateral and multilateral negotiations on commercial issues to create a more unified front related to threats from countries such as China and Russia. This deal may be the beginning of similar deals for other countries and deeper negotiations with the EU on trade issues.”

James C. Shehan, Chair of the firm’s FDA Regulatory practice, speaks with Managed Healthcare Executive about the FDA’s criteria for evaluating the safety and need for a booster shot, including whether it causes adverse reactions and, if so, the severity of those reactions. Shehan notes, “Boosters are … common. For example, people get tetanus shots every 10 years.”

Foreign Investment Watch interviews Doreen M. Edelman, partner and Chair of the firm’s Global Trade & National Security group and number one on the company’s Top Advisors 2021 list, about President Joe Biden’s approach to China, the latest governmental trade appointments, a possible U.S. investigation into Chinese subsidies under Section 301 of the U.S. trade law, and other government actions that target China. “One example is Section 889 of the National Defense Authorization Act, which prohibits any U.S. government agency from buying or doing business with any company that uses telecom equipment that uses components from one of the targeted Chinese companies,” Edelman says. “These are broad provisions with the focus being to ostracize China.” She adds, “I don’t think either side wants … [a trade war] because of the market implications, and Biden has pledged to be more multilateral in his approach. Let’s hope that the ongoing bilateral discussions are substantive, and the new appointees can get engaged quickly.”

Edelman continues: “U.S. business and consumers were, and are, the victims of the Section 301 tariffs. No one thought they would last this long. More tariffs would not be prudent. … The silver lining I see is that trade regulations and tariffs are now issues that senior management can take advantage of to optimize their business if they really understand their options. It is critical to every company’s growth strategy.”

In BioWorld MedTech, James C. Shehan, Chair of the firm’s FDA Regulatory practice, discusses the recent rescission of a 2020 U.S. Department of Health and Human Services (HHS) policy that required signoff by the HHS Secretary on any rulemaking by HHS agencies, including the FDA. Shehan says that, even without this additional requirement, the rulemaking process is cumbersome. He states, “I see the status quo continuing. It will continue to take a long time to issue rules.”

Shehan adds: “[D]elegation of authority in administrative agencies has been routinely upheld by the courts. … [G]overnment agencies in general are allowed to delegate these authorities absent an explicit statutory ban on such practices.” (subscription required to access article)

James C. Shehan, Chair of Lowenstein’s FDA Regulatory practice, explains some lessons that general counsel should learn from the Theranos case in Corporate Counsel. Shehan advises in-house lawyers to look out for certain red flags, such as poor communication or lack of industry expertise in company leadership. He says, “[W]ithout appropriate expertise, bringing any product or service to market could prove an insurmountable obstacle for even the most ambitious start-up.” Shehan further cautions general counsel to “look out for potential conflicts of interest when executives wear multiple hats, as is common at start-ups.” Finally, he says, “[S]ometimes the situation is so bad that you have no choice but to resign.”

In Corporate Counsel, James C. Shehan, Chair of Lowenstein Sandler’s FDA Regulatory practice and former GC at Novo Nordisk, discusses the role of general counsel in helping companies obtain FDA approval for drugs and vaccines. Shehan describes the role of in-house lawyers as more strategic than legal "because there are not often significant legal issues that come up in the approval process." He adds that general counsel can "assist in how you're going to frame the data. You also might assist in figuring out which points need to be emphasized and de-emphasized."

In Law.com, Julie Levinson Werner, partner in the firm’s Employment Counseling & Litigation group, discusses how curbing employment noncompete agreements affects worker mobility and economic growth. Werner says, “If you look at New York City, if you look at Austin, Texas, if you look at Miami, there’s a vibrant startup community in all three of these locations, and they all have clearly established laws protecting the enforcement of noncompetes in the appropriate circumstances. And it has not hindered development in those areas.”

In this video on SupplyChainBrain, Laura Fraedrich, senior counsel in Lowenstein’s Global Trade & Policy group, discusses why the United States and the European Union seem to have set aside their longstanding dispute over aerospace subsidies. Fraedrich says the shift indicates a mutual desire “to come together and address trade disputes elsewhere in the world, especially those relating to China. They see bigger fish to fry.”

In Foreign Investment Watch, Doreen M. Edelman, Chair of the firm’s Global Trade & National Security group, and Christian C. Contardo discuss a recent report by the Defense Critical Supply Chain Task Force and its recommendations for building U.S. supply chain resilience, including the possibility of requiring companies to disclose foreign capital they receive from adversaries. Edelman says, “I am advising companies, not just technology and defense providers, to focus on their supply chain.” Regarding the possibility of creating an inclusionary process that exempts “trusted partners” from CFIUS requirements, Edelman predicts “a formal or informal loosening of the requirements for trusted partners,” despite the fact that these relationships are always subject to “a fact specific transaction review.” Contardo observes that these recommendations “are in addition to voluntary incentive-based supply-chain security programs such as the Department of Defense Trusted Capital program, [which] matches vetted capital providers to U.S. businesses working with the DoD in key technology sectors as a way for the businesses to raise necessary funding to grow without risking investment from countries of concern to the DoD.”

James C. Shehan, Chair of the firm’s FDA Regulatory practice, talks to Corporate Counsel about the role of general counsel in negotiating the proposed $26 billion settlement of 4,000 opioid epidemic-related lawsuits across the country. Shehan says, “General counsel play a prominent and often primary role in the case of a settlement.”

In an interview on AM Best TV, Kathleen A. McGee, partner in the firm’s Emerging Companies & Venture Capital group and White Collar Defense practice, addresses what she describes as the “emerging epidemic” of ransomware and how companies can mitigate possible damage to their businesses. McGee says, “There is no stopping a nation state when a nation state wants to get into your infrastructure. … Companies need to address the new normal by putting their money where it counts.” She warns that, despite the experience of Colonial Pipeline in recovering much of its losses, there is “no guarantee that the government will be able to recoup your losses, but it is a best practice to notify law enforcement.” McGee further notes that insurance companies have an important role to play by encouraging best practices: “The probability of being impacted by a ransomware attack is much higher than other acts of god, and insurance companies need to reflect that.”

Zarema A. Jaramillo, Managing Partner of Lowenstein’s Washington, D.C. office, is featured in Northern Virginia Technology Council’s (NVTC) member spotlight, where she discusses the firm’s growth and how it is serving technology clients in the Washington area. Jaramillo says, “The synergy of our core practices here in D.C. seamlessly complements the firm’s wide range of transactional work in technology, private equity, and life sciences, as well as others, and enables us to offer a multidimensional, global perspective to businesses operating around the world.” She adds that the D.C. office is rapidly growing “because we are attracting the highest caliber of attorneys who are able to collaborate in a great culture that encourages an entrepreneurial mindset. … As a woman-led office, we are focusing our efforts on making it a place where all lawyers can grow and succeed and shape their practices in a way that allows them to be all that they can be.”

Doreen M. Edelman, Chair of the firm’s Global Trade & National Security group, speaks to Foreign Investment Watch about preemptive disclosures of non­notified CFIUS transactions involving SPACs, where companies state that they will not be submitting a declaration with CFIUS unless they are requested to do so. Edelman calls this approach “a proactive, low risk way to let regulators know that the CFIUS process was not ignored or flouted.” She adds that “by making this statement to the SEC, at least it’s on record somewhere that the parties carefully reviewed the transaction for national security concerns” (subscription required to access article).

Foreign Investment Watch recently ranked Edelman as number one on its Top Advisors 2021 list of lawyers who provide legal advice concerning national security reviews of foreign investments in the United States and abroad

James C. Shehan, Chair of Lowenstein’s FDA Regulatory practice, comments in several media outlets on the U.S. Food & Drug Administration’s controversial, landmark approval of a new drug for patients with Alzheimer’s. In Reuters and National Post, he observes: “The agency has gotten comfortable with the accelerated approval pathway." In Law360, Shehan adds: "It has all the ingredients of a good FDA story.”

Lowenstein's representation of PeriGen Inc. (PeriGen), a leading provider of perinatal health care software solutions, in its sale to Halma plc is noted in the Global Legal Chronicle. The Lowenstein deal team includes Sam E. Khan, Christopher C. Henry, Rachel Ingwer, Lauren M. Troeller, Diana Kim, Kimberly E. Lomot, Megan Monson, Taryn E. Cannataro, Eric Jesse, Bryan Sterba, Matthew P. Hintz, David Toma, James C. Shehan, Edgar R. Hidalgo CIPP/US, Mark S. Heinzelmann, Emily B. Sklar, Megan Williams, Latoya Bethune, and Amanda Sewanan. View Lowenstein's news announcement about this transaction.

James C. Shehan, Chair of Lowenstein’s FDA Regulatory practice, comments in Law360 on a ruling by the D.C. Circuit Court that requires the U.S. Food and Drug Administration (FDA) to be more careful in designating products as either drugs or medical devices where the two definitions overlap. Shehan says, “The ruling will make it harder for the FDA to default to calling a product a drug when it fits within the definitions of both drug and device.”

Zarema A. Jaramillo is featured in a recent Lowenstein video that describes the ways in which our Washington, D.C., office serves the technology community in the greater D.C. metro area. The video appears in Potomac Tech Wire, a e-newsletter that provides a daily summary of the area's most important technology news.

Nicholas San Filippo IV is interviewed on the Deep Wealth: The Sell My Business Podcast, where he discusses proven strategies for achieving successful M&A deals. San Filippo talks about common mistakes business owners make, the impact of the COVID-19 pandemic, and why trust is the currency in mergers and acquisitions. San Filippo also explains why he became an M&A lawyer: “I feel like Superman when I come in and I'm able to help entrepreneurs go from paper wealth to liquid wealth."

Mary J. Hildebrand CIPP/US/E, founder and Chair of Lowenstein’s Privacy & Cybersecurity group, speaks with Law360 about the need for federal regulation governing companies’ collection and maintenance of COVID-related health information, including who has and has not received a Covid-19 vaccine. Hildebrand says, “The current situation with COVID-related data underscores the compelling need for federal action…California residents have been accorded certain rights to personal information under state law which may be helpful, but protection of this sensitive data should not depend on where you live."

In The American Lawyer, Chair and Managing Partner Gary M. Wingens discusses how the firm performed “shockingly well given what was going on in the world” in 2020. Wingens credits the firm’s investment funds, tech, life sciences, bankruptcy, and capital markets practices, in addition to engagements in venture capital and private equity. “People need lawyers as things change,” he says. Wingens is optimistic about 2021: “I do feel that we are at the beginning of a whole new economic cycle,” he says. “I think there’s going to be an enormous amount of investment activity.”

James C. Shehan, Chair of the firm’s FDA Regulatory practice, tells Law360 there is no cause for concern about the lack of a confirmed FDA commissioner at this point in the Biden administration. He says: "Is it a problem? I'd say no. … The core of the agency continues to function well, so there's no immediate concern." Shehan adds that a confirmed leader is less involved with day-to-day matters and more focused on setting the long-term agenda: "That only happens when you have someone who is officially in charge and is going to be there for a while and says, 'This is something new we should do.’”

Laura Fraedrich is interviewed in Foreign Investment Watch about foreign direct investment requirements, CFIUS filings, and mitigation negotiations. Regarding the incoming administration, she says, “I anticipate that the United States will return to a more multilateral approach. … Specifically, I think we will see a return to a cooperative effort to restoring the dispute settlement arrangement at the WTO and to the negotiation of multilateral trade agreements.” Fraedrich notes that “during the past five years, the majority of mitigation agreements have related to preventing access to data or technology by the foreign investors,” and she advises companies to “carefully consider where the national security concerns may lie and determine the cost of potential mitigation arrangements when negotiating. This is because certain mitigation requirements might impact the benefit of the bargain and thus valuation. Finding this out after the deal has been struck can create a difficult situation.”

Fraedrich encourages companies to consider foreign investment and ownership implications early in the transaction: “A company organized in the United States might be a foreign entity if there is foreign ownership and control. A joint venture that is organized in a foreign country might be subject to CFIUS jurisdiction if a U.S. business has been contributed. The new rules for private equity funds are complicated, and if fund managers are not careful, a U.S.-organized fund can be a foreign person.”

Real Estate NJ notes the elevation to partner of Daniel A. Suckerman of Lowenstein’s Real Estate practice. The article includes a quote by the group’s Chair, Ted Hunter: “Dan has been an integral part of our real estate team for many years. He has handled numerous headquarters leases, major acquisitions, financings and development transactions — all with equal skill and savvy.”

Doreen M. Edelman is interviewed on the podcast FCPA Compliance Report on why every compliance professional needs to be ready to comply with CFIUS and where CFIUS may be headed under the Biden administration. Edelman urges parties to a transaction to consider‒long before closing‒any factors that could trigger CFUIS scrutiny, such as how the technology in question will be classified for exports, who are the ultimate beneficiaries, and possible exit strategies.

Jonathan L. Lewis's arrival to Lowenstein Sandler's Washington, D.C., office as a partner in the firm’s Antitrust/Competition practice is highlighted in The American Lawyer (October 14, 2020; October 16, 2020; October 26, 2020; January 4, 2021), Competition Policy International, General Counsel News, Reuters' The Daily Docket, Bloomberg Law, Law.com, Global Competition Review, Law360 (October 16, 2020; October 26, 2020), and ICLG. (subscription required to access certain content) View Lowenstein's news announcement about Lewis's arrival to the firm.

In an article in Tax Notes Federal discussing the Biden administration’s likely approach to trade issues, Doreen M. Edelman says she does not foresee any immediate removal of section 301 tariffs against China in the near future: “I think … [President Biden is] … going to look at them. I don’t think he’s going to come in and immediately remove them in an executive order.” Regarding the ongoing dispute between the United States and the EU about Boeing-Airbus, Edelman state that “the administration will likely push for negotiations to get ‘back on track with the EU’ as part of a move toward multilateralism.”

Doreen M. Edelman, Chair of the firm’s Global Trade & National Security group, discusses in Law360 anticipated trade issues for the incoming administration, such as the digital service tax programs increasingly imposed in Europe that are stirring controversy among Silicon Valley companies. "Digital taxes will also be discussed [with the EU], and the Biden administration will want to be part of a multilateral deal," Edelman predicts. "Biden likes to make all sides appreciate the deal, which may be difficult."

Laura Fraedrich's arrival to Lowenstein Sandler's Washington, D.C., office as senior counsel in the firm's Global Trade & Policy practice is noted in Bloomberg Law, General Counsel News, The American Lawyer, and The Washington Post. View Lowenstein's news announcement about Fraedrich's arrival to the firm.

In Part 2 of the American Association of Bank Directors’ podcast, Calling All Bank Directors: What You Need to Know Before and After Your Bank Renews Its D&O Insurance, Lynda A. Bennett, Chair of the Insurance Recovery group, discusses how banks and their directors can successfully access their coverage; the importance of understanding the scope of the bank’s indemnification of directors and officers before the policy terms are finalized; how the definition of “claim” in the policy may affect coverage for regulatory investigations and other matters; how to properly and timely file and manage a claim; and how to negotiate the language in the policy without necessarily increasing the cost of the coverage. She notes that “one of the biggest mistakes we see clients make is not providing immediate notice of claims. … A claim is defined in all of these policies quite broadly to include any written demand for monetary or nonmonetary relief.”

Lynda A. Bennett, Chair of the Insurance Recovery group, addresses the current D&O insurance market, the most important provisions in a D&O policy, the most common mistakes that banks make regarding D&O insurance, and how banks may achieve the best possible insurance coverage on Calling All Bank Directors: What You Need to Know Before Your Bank Renews Its D&O Insurance, Part 1, the podcast of the American Association of Bank Directors.  Bennett calls the discussion especially timely as, in her 26 years of practice, she has never seen such a volatile D&O market for bankers and bank directors, as well as for other companies in other industries.

“The market is incredibly in flux, premiums are skyrocketing, self-insured retentions are going up, capacity in the market is shrinking and particularly drying up in certain industries where it is difficult to keep the full tower of coverage that you have and in some instances to stay with the same carriers that have historically been part of your insurance program; and last, we have also seen a restriction in terms, and that is very specific to the banking industry, as insurance companies are taking a very careful and hard look at the scope of coverage that they’re going to provide for regulatory investigations and other informal inquiries conducted by governmental officials.” She adds that COVID-19 has made all these issues even more acute, so it is critically important that companies with coverage coming up for renewal reach out to insurance professionals in order to be prepared for a detailed underwriting process that could be “potentially painful.”

Michael B. Himmel, Chair of the firm’s White Collar Defense practice, speaks to the FTI Journal about the importance of conducting internal investigations in a timely manner, even when faced with the challenges of remote work environments in a global pandemic. Himmel says, “When dealing with allegations, an organization’s action or inaction can mean the difference between being granted a deferred prosecution agreement from the Department of Justice or not. … From the civil perspective, how quickly an audit committee responds to an allegation can determine whether a derivative lawsuit has merit.”

Doreen M. Edelman comments in Business Insider on the risks for venture capital firms under the Trump administration’s increased scrutiny of foreign investment, as illustrated by the executive order banning TikTok in this country and ordering its parent ByteDance to undo a years-old merger that led to the app's expansion around the world. "I don't feel that enough of the venture companies and the [private equity] backed companies in tech and data understand that this ... could be a real issue," she says.

She explains the broad reach of the Committee on Foreign Investment in the United States (CFIUS), which can not only review but also force changes to deals closed long ago. “There’s no time limit,” she says. There is also no requisite size for a company to come under CFIUS review. "There's no de minimis," Edelman continues. "There's no lower threshold." (subscription required to access article)

Lowenstein's representation of Spring Bank Pharmaceuticals, Inc. (Nasdaq: SBPH) in entering into a definitive share exchange agreement with F-star Therapeutics Limited to acquire all of the outstanding share capital of F-star in exchange for newly issued shares of Spring Bank in an all-stock transaction is highlighted in the Global Legal Chronicle. The Lowenstein deal team included John D. “Jack” Hogoboom, Daniel C. Porco, and Madeline Roe (Corporate); Brian A. Silikovitz and Kristin V. Taylor (Tax); Robert J. Paradiso (Patent Counseling & Prosecution); and Andrew E. Graw and Christine Osvald-Mruz (Executive Benefits & Executive Compensation). View Lowenstein's news announcement about this transaction.

Doreen M. Edelman is interviewed by Foreign Investment Watch, a publication focused on the intersection of national security and foreign investment, which recently named her one of its top ten advisors in 2020. Edelman discusses the reasons why a CFIUS review is critical for startups, private equity, and venture fund companies, and she looks at the new real estate provisions of FIRRMA, which cover “not just investment in a U.S. business with real estate but also leases, purchased land, and concessions.” She also addresses the Trusted Capital Program, a Department of Defense program that matches prescreened investors with companies working on technology or products of national security interest. Finally, Edelman looks at reporting obligations under the International Investment and Trade in Services Survey Act, which requires all U.S. businesses to file reports identifying foreign direct investment that results in a foreign entity owning or controlling 10 percent or more of a U.S. business. 

Lowenstein’s representation of Spring Bank Pharmaceuticals, Inc. in its definitive share exchange agreement with F-star to combine as F-star Therapeutics, Inc. is reported in Canada Stock Watch. The Lowenstein deal team included John D. “Jack” Hogoboom, Daniel C. Porco, and Madeline Roe (Corporate); Brian A. Silikovitz and Kristin V. Taylor (Tax); Robert J. Paradiso (Patent Counseling & Prosecution); and Andrew E. Graw and Christine Osvald-Mruz (Executive Benefits & Executive Compensation). View Lowenstein's news announcement about this transaction.

Citybizlist, Marketwatch, GlobeNewswire, M&A Navigator, MassDevice.com, the Global Legal Chronicle, Law360, and MD and DI Online report the sale of Lowenstein client Artegraft to LeMaitre Vascular for $90 million. The Lowenstein deal team includes Michael J. Lerner, Michael Reinhardt, Annie Nazarian Davydov, Darren Goodman, Robert J. Paradiso, Mary E. Storella, Brian A. Silikovitz, Sophia Mokotoff, James C. Shehan, Norman W. Spindel, Taryn E. Cannataro, Danielle M. Falzone, and Jesse S. O’Connell. (subscription required to access certain content) View Lowenstein's news announcement about this transaction.

James C. Shehan, Chair of Lowenstein’s FDA Regulatory practice, is quoted extensively in an article published by the Regulatory Affairs Professionals Society that summarizes an expert panel discussion on The Orphan Drug Act at BIO Digital 2020. Noting that the definition of an orphan drug has not changed since the law passed in 1983, he says that “[s]ince the passage of the act there’s been a steady rise in products that are designated by the FDA as orphan drugs and that ultimately are approved and reach the market.” Shehan mentions a 2018 Government Accountability Office that found “more could be done to bring rare disease drugs to market,” and that the Tax Cuts and Jobs Act of 2017 reduced the orphan drug tax credit from 50 percent to 25 percent. The panel at BIO Digital included Nick Leschly, CEO of bluebird Bio; Laura Clague, CFO of Retrophin, Inc.; Natasha Bonhomme, Chief Strategy Officer of the Genetic Alliance; and Bonnie Schneider, Director of the IgAN Foundation.

Lowenstein's representation of issuer Celldex Therapeutics, Inc. (Celldex) (Nasdaq: CLDX) in connection with the company’s approximately $150 million public offering of common stock is highlighted in the Global Legal Chronicle. The Lowenstein team included Anthony O. Pergola, Alan Wovsaniker, Kate Basmagian, Alexander Dinur, Madeline Roe, Sarah Gore, and Robert J. Paradiso. View Lowenstein's news announcement about this transaction.

Lowenstein's representation of Provention Bio, Inc., (Nasdaq: PRVB) in its underwritten public offering, which grossed approximately $110 million, is highlighted in the Global Legal Chronicle. The Lowenstein deal team includes Michael J. Lerner, Steven M. Skolnick, James C. Shehan, Sarah P. Cole, and Timothy N. MacKay. View Lowenstein's news announcement about this transaction.

Doreen M. Edelman discusses the increase in CFIUS filing requirements and regulatory scrutiny that private equity firms face for deals involving foreign capital in Fundfire. She notes the reputational impact for companies in addition to the risk of civil and criminal penalties. Edelman says, “[If] you cannot find a way to mitigate with the U.S. government and unwind your deal to a certain extent to reduce the national security issue, you can have to divest, or the foreign party could have to divest from the U.S. business. … It’s just time, money, and embarrassment." (subscription required to access article)

Mary M. Collins, President and CEO of the Media Financial Management Association, discusses the article, “Redesigning the Workplace,” by Amy Komoroski Wiwi and Lauren M. Hollender (published in May/June 2020 issue of The Financial Manager), in her column for TVNewsCheck. Collins reiterates the authors’ counsel on employment issues arising from working from home during the pandemic, including the classification of independent contractors and possible audits, remote privacy concerns and training, and Federal Fair Labor Standards Act (FLSA) requirements. She also discusses their points about joint-employer liability, which can vary by jurisdiction, for companies using staff through agencies.

Dealreporter spoke to Doreen M. Edelman about a new Treasury Department proposal that will clarify when inbound investors of U.S. critical technologies need to make a mandatory filing with CFIUS. She says this will narrow the definition of transactions covered by the Foreign Investment Risk Review Modernization Act, making it less “fuzzy” and subjective. She adds that the “same analysis that parties have used to determine whether they are subject to export controls will help them determine whether their CFIUS filings are mandatory or not.” (subscription required to access article)

Boardroom Insider features comments by Lynda A. Bennett on D&O liability risks in the wake of COVID-19. She notes that insurance companies will “take a careful look at your public disclosures on preparations and risk factors” and that a legitimate “notice of circumstances” now can lock in coverage under current terms for possible future claims. Bennett also observes: “There’s going to be a scramble to keep Side A coverage in place,” with the price for this kind of personal protection likely to go up. Finally, she cautions that “[t]here will be no more rote renewals.” Bennett expects tighter terms, broader exclusions for risks associated with pandemics, more questions about preparedness, and increased premiums from fewer providers. (subscription required to access article)

Christopher Porrino, former New Jersey Attorney General and Chair of Lowenstein’s Litigation Department, speaks to ROI-NJ about law enforcement’s aggressive pursuit of alleged price gougers. He says, “Now, not only is the state pursuing civil penalties against those who price-gouge, for the first time in memory, federal authorities are seeking criminal penalties using a 1950s era statute. … The pursuit of criminal penalties in New Jersey is unprecedented in this context, and those businesses that enter the supply chain for scarce personal protective equipment need to beware. This aggressive criminal enforcement is not something legal scholars and law firms predicted, but it is happening at a fevered pace right now in New Jersey and around the country.”

Kathleen A. McGee is quoted in Law360 on the federal government’s evolving guidance about qualifications for SBA PPP loans and the next steps for companies now that the deadline to return those loans has passed. "Initially, there weren't a lot of questions," she says. “Although from the start we were advising clients that … you did have to show need and you had to establish that need was immediate need." When the SBA issued clarifications in late April regarding ownership and affiliation that especially affected technology and VC-backed companies, “that's when people really started to, I would say, panic," she says. McGee notes that even companies with loans under $2 million may still face Department of Justice scrutiny and possible whistleblower suits under the False Claims Act. (subscription required to access article)

In Inc., Julie Levinson Werner discusses how businesses should plan to reopen and stay open post-COVID-19. She recommends training staff on new cleaning and health protocols such as temperature-taking, in addition to rethinking where workers sit in relation to each other. She warns, “Companies that don't outline these new protocols clearly could face official complaints and reputational damage.”

Lowenstein's representation of Delcath Systems, Inc. in an underwritten public offering of shares and warrants is noted in the Global Legal Chronicle. The Lowenstein deal team included John D. "Jack" Hogoboom, Robert J. Paradiso, Brian A. Silikovitz, James C. Shehan, Sarah P. Cole, Michael T. Melchiorre, Erica Perlmutter, and Kristin V. Taylor. View Lowenstein's news announcement about this transaction.

The arrival to Lowenstein of senior counsel Mary E. Storella as Vice Chair of the Life Sciences group and head of Life Sciences Transactions is highlighted in NJBIZ, Private Equity Wire, Law.com (New Jersey Law Journal), Bloomberg Law, Mergers & Acquisitions, and The Deal. View Lowenstein's news announcement about Storella joining the firm.

Ed Zimmerman, partner and Chair of Emerging Companies & Venture Capital (fka, The Tech Group), is quoted in Business Insider discussing the SBA’s issuance of new rules and guidance that may retroactively disqualify many venture-backed startups from receiving small business loans as part of the federal government’s coronavirus relief effort. Zimmerman notes that some companies are already paying back funds they received in response to the new rules after being encouraged to apply for the program by Treasury Secretary Steve Mnuchin. He states that the SBA and Treasury Department have “really muddied the water” with the latest guidelines. (subscription required to access article)

In The Deal, Steven E. Siesser discusses the likely rise in bankruptcy filings for private equity-backed companies facing fiscal challenges in the wake of the COVID19 pandemic. He says, “You’ll see bankruptcies uptick in the coming months … It hasn’t really started yet. There’s a ton of relief money being paid by the government right now. Companies are still paying their employees and getting by.”

Bloomberg Businessweek references Lowenstein’s Updates on Tax Deadlines and Key Tax Provisions of the CARES Act, authored by Brian A. Silikovitz, Andrew E. Graw, Lesley P. Adamo, Darren Goodman, and Robert B. Krieger and republished in JD Supra. The article recommends the employee retention tax credit for business owners who have not received adequate relief from either the SBA’s Paycheck Protection Program (PPP) or Economic Injury Disaster Loan (EIDL) program.

In Built In, Ed Zimmerman, Kathleen A. McGee, and Kimberly E. Lomot discuss the confusion regarding startups' eligibility under PPP for SBA loans, including how venture capital-backed growth companies should consider certifying “need” under the CARES Act. “The reporting in the press was, ‘Startups are totally ineligible or almost totally ineligible,’” says Zimmerman. “But that’s not what the law says. That’s analysis under Section 103, and the proper way to do the analysis is under 301.” He goes on to clarify under what conditions “negative control” by minority owners may constitute affiliation so as to bar PPP loan eligibility, and how to avoid this through irrevocable waivers or amended charters.

Both Zimmerman and McGee emphasize the importance of documentation. McGee, former Bureau Chief at the New York State Attorney General’s Office, explains the potential risk of future prosecution for companies applying for PPP without having properly assessed the “necessity” certification: “If it is demonstrable on the budget in the Excel spreadsheet you’re keeping that things are going to get much tighter because of COVID-19, then I think you’re justified. … But you have to have that good faith justification. If you have a year of bank, it’s probably going to be a flag raised for regulators.”

Lomot, who has years of experience counseling both borrowers and lenders on SBA loans, also urges caution in taking the certifications seriously: “eagerness to claim available funds…could get startups in trouble if they’re not applying in good faith.”

Ed Zimmerman and Kathleen A. McGee of Lowenstein’s Emerging Companies & Venture Capital group are quoted in The New York Times and Reuters on the risks for venture-backed startups seeking government stimulus aid. McGee warns companies with large cash reserves that applying for SBA loans now could “probably … be a flag raised for regulators who are combing through these applications at another time.”  Zimmerman also advises caution: “One thing that I have said to one or two clients is you might not like me very much today or in three months, but I think you’ll like me four years from now when you’re reading about investigations and private lawsuits in the paper and you don’t have this in your background.”

Lowenstein's representation of Veronis Suhler Stevenson in the completion of its investment (with NewSpring Health Capital) in the BRC Recovery Family of Programs is noted in the Global Legal Chronicle. The Lowenstein deal team included Steven E. Siesser, Eileen Overbaugh, Traci M. Tomaselli, Brooke A. Gillar, and Lesley P. Adamo. View Lowenstein's news announcement about this transaction.

Robert M. Hirsh is quoted in Bloomberg regarding the current state of bankruptcy filings and the means by which the court system is adapting in order to accommodate the anticipated wave of bankruptcy filings following the coronavirus pandemic.

Doreen M. Edelman is quoted in The Wall Street Journal’s article on calls to delay or roll back tariffs during the COVID-19 pandemic, which are currently being determined on a case-by-case basis. She notes: “Having a tariff that is intended to punish China, but is being paid for by middle-America consumers who may currently be out of work, seems unfair at best and counterproductive.” (subscription required to access article)

The arrival of former U.S. Treasury national security lawyer Christian C. Contardo to Lowenstein’s Global Trade & Policy practice in the firm’s Washington, D.C., office is noted in Bloomberg Law, Washington Business Journal, General Counsel News, The Washington Post, Reuters, and The Deal. Contardo has over a decade of experience in federal agencies such the Department of Homeland Security, Immigration and Customs Enforcement, and Treasury, including with the Office of Foreign Assets Control (OFAC) and the Committee on Foreign Investment in the United States (CFIUS). 

In Tax Notes, Doreen M. Edelman comments on requests made by U.S. trade groups asking the Trump administration to remove section 301 tariffs in light of the financial uncertainty surrounding the coronavirus pandemic; she notes that exclusions alone may not be sufficient to help U.S. businesses. “These tariffs were intended to hurt China, but trade policy experts knew when the announcement was made that the administration was mixing apples and oranges," she says. "The companies were to 'take one for the team' and take the long view that the policy to alienate China was a good policy. The effect of the virus on retail companies will put the icing on the cake for retail companies.”

Doreen M. Edelman, Chair of the firm’s Global Trade & National Security group, addresses the risks for U.S. dealmakers posed by the new rules implemented by the Committee on Foreign Investment (CFIUS) in an article in The Deal. The February 13^th implementation of the Foreign Investment Risk Review Modernization Act, or FIRRMA, extends the authority of the Committee in ways that will impact “[t]ech startups, private equity firms, hedge funds, C-suite executives and other stakeholders,” says Edelman, warning that “transactions could be jeopardized if parties don’t fully understand the new regulatory regime adopted by the Treasury Department, which oversees the nine-member government panel.” She adds that stakeholders must carefully classify their products and technologies; in “some cases, tech companies may not realize they have Chinese investment that could attract the committee’s attention or may wrongly assume that a small stake isn’t a concern.”

Lowenstein’s representation of Timber Pharmaceuticals in its definitive merger agreement with BioPharmX Corporation was noted in citybizlist, ROI-NJ, BioWorld, and Cision PR Newswire. The Lowenstein deal team included Steven M. Skolnick, Alan Wovsaniker, Alexander Dinur, and Tracy F. Buffer. View Lowenstein's news announcement about this transaction.

Doreen M. Edelman contributes her 2020 predictions on potential legal issues in international trade in Law360. She notes that the Commerce Department has still not developed guidance on a rule, announced in 2018, on which “emerging and foundational technologies” are subject to export controls. She warns that, to date, many owners and developers of, and investors, in technology such as artificial intelligence, 3-D printing, quantum computing, and robotics “have not focused on export control requirements for these technologies. … Thus, these companies must quickly learn when export controls apply” to them to ensure compliance. (subscription required to access article)

Jonathan L. Lewis has been quoted in numerous Law360 articles regarding timely antitrust issues. Articles include: "DOJ’s Heir-Tracking Case Shows Fight For Clear Standard," "DOJ Antitrust Division Gets Off The Sidelines," "Will FTC Win 'Radically Reshape' Cell Patent Licensing?," and "Competition Cases To Watch For The Rest Of 2017." 

James C. Shehan is quoted in the Pink Sheet regarding Sarepta Therapeutics Inc.’s decision to not publicly disclose its submission of a formal dispute resolution request appealing the FDA’s rejection of the drug Vyondys 53. Shehan notes that the legal standard for determining whether information such as this must be disclosed is how material is it to an investor’s buy or sell decision and that, because companies don't often win formal dispute resolutions with the FDA, Sarepta’s decision to not disclose the appeal’s existence could be legally permissible. (subscription required to access article)

Max Karpel's arrival at Lowenstein as a partner in the Investment Management group is noted in Bloomberg Law – Big Law Business, General Counsel News, NJBIZ, Reuters, and The Deal. (subscription required to access certain content) View Lowenstein’s news announcement about Karpel joining the firm.

Lowenstein's representation of W2O, the leading independent provider of analytics-driven, digital-first marketing communications to the health care sector, in the acquisition of Arcus Medica, a recognized leader in medical and scientific communications, highlighted in the Global Legal Chronicle. The Lowenstein deal team included David L. Goret, Marita A. Makinen, Andrew P. Erdmann, Matthew Tippy, Eugene R. Cheval, Tracy F. Buffer, Michael Walutes, Sophia Mokotoff, Megan Monson, Matt Savare, Bryan Sterba, Mary J. Hildebrand, Manali Joglekar, Carly S. Penner, Amy Komoroski Wiwi, and James C. Shehan. View Lowenstein's news announcement about this transaction.

Herschel S. Weinstein provided legal counsel to Hildred Capital Management, LLC as co-counsel in its recapitalization of DermCare Management, LLC with Gemini Investors; the transaction was mentioned in the Valdosta Daily Times, Business Wire, ABL Advisor, and the Global Legal Chronicle.

Lowenstein’s role in the merger agreement between firm client Sonnet BioTherapeutics and Chanticleer Holdings is mentioned in Proactive Investors USA & Canada, ROI-NJ, citybizlist, GlobeNewswire, and the Global Legal Chronicle. The Lowenstein deal team included Steven M. Skolnick, Sarah P. Cole, and Tracy F. Buffer.

James C. Shehan is quoted in The Center for Biosimilars in an article discussing the nomination of Stephen Hahn to be the next FDA commissioner and whether his selection would mean continued advancement for biosimilars, as was the case during Scott Gottlieb and Ned Sharpless’s tenures. Shehan notes a major shift in the U.S. market’s need for biosimilars, with Gottlieb’s time as commissioner representing a “quantum leap in terms of activism.”

Law360 reports on the successful motion for summary judgment brought by Matthew Boxer and a team from Bredhoff & Kaiser PLLC in connection with RICO claims by health care facilities against three health care worker unions.

The transition of leadership of Lowenstein Sandler’s D.C. office to Antitrust/Competition partner Zarema A. Jaramillo was covered in Bloomberg Law – Big Law Business, General Counsel News, The Hill, The Deal, and The Washington Post. Jaramillo is set to take over on January 1, 2020, from Jeffrey Blumenfeld, who founded the D.C. office in 2014 and will remain Co-chair of the firm’s Antitrust/Competition practice.

James C. Shehan, Chair of Lowenstein’s FDA Regulatory practice, comments in Law360 on the D.C. federal court ruling that struck down the Trump administration rule requiring drug prices to be disclosed in TV ads. U.S. District Judge Amit P. Mehta found that there was no basis in either statute or legislative history to support the authority of Department of Health and Human Services (DHHS) to make such a rule. Shehan notes the judge’s “powerful argument” that if DHHS’s general powers were extended to include the authority to force price disclosure in commercials, “it could also use that authority” to regulate many other subjects not identified in the law, “like medical school tuition rates or hospital executive compensation.” (subscription required to access article)

Lowenstein Sandler’s role as legal counsel to Aceto Corporation in its Chapter 11 bankruptcy filing and in the proposed $338 million sale of its chemical business assets to New Mountain Capital is highlighted in Bankrupt Company News, MarketWatch, GlobeNewswire, Markets Insider, StreetInsider.com, EIN Presswire, MarketScreener.com, and the Global Legal Chronicle (May 20, 2019; June 22, 2019). The firm’s role as legal counsel in Aceto’s sale of subsidiary Rising Pharmaceuticals, Inc. is noted in The Associated Press, MarketScreener.com, and the Global Legal Chronicle. (Lowenstein team: Kenneth A. Rosen, Steven E. Siesser, Paul Kizel, Michael S. Etkin, Jeffrey Cohen, Wojciech F. Jung, Philip J. Gross, Michael Savetsky, and Michael Papandrea.) (subscription required to view certain content) View Lowenstein’s news announcements about this representation: March 18, 2019; May 13, 2019.

James C. Shehan, Chair of Lowenstein’s FDA Regulatory practice, is interviewed on the “Not So Different” podcast by the Center for Biosimilars on the FDA’s recently released final guidelines on demonstrating interchangeability, which Shehan knows well because he helped craft the sections of the Biologics Price Competition and Innovation Act that govern interchangeability. He also addresses the upcoming transition of insulin to its regulation as a biologic instead of as a drug, and the possibility of it being categorized as an interchangeable one day.

Morningstar Inc., Yahoo Finance, BioSpace, Cision PR Newswire, Chain Drug Review, and the Global Legal Chronicle note Lowenstein Sandler as counsel to Crown Laboratories, Inc. and Hildred Capital Partners LLC in Crown’s acquisition of the North American distribution rights to Keri from GlaxoSmithKline plc (NYSE: GSK). (Lowenstein deal team: Herschel S. Weinstein, Sam E. Khan, Mitchell McDonald, James C. Shehan, Matthew P. Hintz, Michael A. Buxbaum, Matthew Tippy, Erica Perlmutter, Jeffrey M. Shapiro, and Jack Sidorov.) View Lowenstein’s news announcement about this transaction.

Lowenstein Sandler is highlighted in Bloomberg Law – Big Law Business and the Global Legal Chronicle for its role in recovering full coverage litigation fees in an ongoing suit against its client’s insurer. The Lowenstein team included Lynda A. Bennett and Eric Jesse.

Lowenstein’s 2019 promotion of seven lawyers to partner and six to counsel (including three women in each category) is noted in Bloomberg Law – Big Law Business. These promotions are also highlighted in LawFuel, The Deal, and the Commerce and Industry Association of New Jersey’s (CIANJ) Business Beat newsletter, with Lesley P. Adamo, Dmitry Andreev, Marc S. Kurzweil, James B. O’Grady, Eileen Overbaugh, Peter Slocum, and Julie Levinson Werner highlighted as newly elected partners and Brandon Fierro, Joseph G. Jones, Robert Lynn, Brianne Perlman, Nedda N. Salehi, and Leah Satlin listed as promoted to counsel. Gary M. Wingens is quoted regarding the critical role these lawyers will play in the firm’s continued success. Law360 notes our partner elevations in an article highlighting firms' Q1 promotions. (subscription required to access certain content) View Lowenstein’s news announcement about these promotions.

A video interview with  James C. Shehan, Chair of Lowenstein’s FDA Regulatory practice, on the FDA’s new approach to citizen petitions aimed at delaying market entry of products, was published on the CenterForBiosimilars.com. Shehan explains that the agency has issued more details on the criteria it will use in deciding whether a petition’s primary purpose is to delay generic competition.

James C. Shehan is quoted in CenterForBiosimilars.com, BioPharma Dive, and Modern Healthcare discussing what the biosimilars industry will look like once FDA Commissioner Scott Gottlieb, MD steps down this April. Shehan notes that Gottlieb represented “a quantum leap in terms of activism” and “has gotten far and away the highest job marks of any commissioner we’ve seen, particularly when you consider that he has gotten respect across the board, which is unusual”, further noting the change in approach to the biosimilars market Gottlieb has taken during his tenure at the FDA resulting in a more competitive drug market. Shehan observes that Gottlieb’s legacy will encourage his successors to “be more communicative with the public and more willing to take a role in some of the great public health controversies”, he further provides that the industry’s concern is rooted in the  uncertainty of who the next commissioner will be and if he or she will be able to keep this positive action going.

Lowenstein Sandler’s role as legal counsel to Aceto Corporation in its Chapter 11 bankruptcy filing and in the proposed $338 million sale of its chemical business assets to New Mountain Capital is highlighted in Bankrupt Company News, MarketWatch, GlobeNewswire, Markets Insider, StreetInsider.com, and EIN Presswire. The firm’s role as legal counsel in Aceto’s sale of subsidiary Rising Pharmaceuticals, Inc. is noted in The Associated Press and MarketScreener.com. (Lowenstein team: Kenneth A. Rosen, Steven E. Siesser, Paul Kizel, Michael S. Etkin, Jeffrey Cohen, Wojciech F. Jung, Philip J. Gross, Michael Savetsky, and Michael Papandrea.) (subscription required to view certain content) View Lowenstein’s news announcement about this transaction.

Lowenstein Sandler is noted as lead counsel to Vesey Street Capital Partners, LLC (VSCP) in their recapitalization of Elite Body Sculpture as published in The PE Hub Network, Cision PR Newswire, and The Business Journals (Lowenstein deal team: Marc B. Kramer, Brooke A. Gillar, Steven E. Siesser, Lowell A. Citron, Michael Walutes, Lesley P. Adamo, Eileen Overbaugh, Elisia M. Klinka, Nicholas Gonski, Darren Goodman, Megan Monson, Eric Jesse, Alanna Sandoval, Jeffrey M. Shapiro, Jack Sidorov, Mark P. Kesslen, Paul M. Krueger, Michael A. Buxbaum, Norman W. Spindel, Mary J. Hildebrand, Bryan Sterba, Manali Joglekar, and Stuart S. Yusem.)

Lynda A. Bennett comments on the Vanderbilt Co v. Hartford insurance case regarding coverage for asbestos injury claims, noting her optimism that the Connecticut Supreme Court justices will affirm the appellate panel's recognition of the unavailability rule, which maximizes coverage available to policyholders facing asbestos claims, as published in Law360. Bennett states, “What carriers are trying to do is expand the allocation period to spread it into more policy years, in order to artificially block full recovery under the policies that were purchased." She further states, “If the allocation period includes years in which the policyholders could not purchase insurance, the practical implication is that the insurers that did take on that risk will take on a smaller share."

Business Wire, MarketWatch, Pharmaceutical Business Review, Cosmetics Technology, ABF Journal, Cision PR Newswire, and the Tullahoma News note Lowenstein Sandler as counsel to Crown Laboratories, Inc. (Crown Laboratories) and Hildred Capital Partners, LLC in Crown Laboratories’ acquisition of the North American distribution rights of five OTC consumer brands from GlaxoSmithKline plc (NYSE: GSK). (Lowenstein deal team: Herschel S. Weinstein, Sam E. Khan, Mitchell McDonald, Sunita Patel, James C. Shehan, Matthew P. Hintz, Sofia Kopelevich, Michael A. Buxbaum, Nicholas Gonski, Matthew Tippy, Jeffrey M. Shapiro, and Jack Sidorov. View Lowenstein’s news announcement about this transaction.

The Washington Post, The American Lawyer, Global Trade Review, Bloomberg Law – Big Law Business, Law360, The National Law Journal, the New Jersey Law Journal, International Trade Today, The Deal, TXF, and citybizlist highlight the launch of Lowenstein’s Global Trade & Policy practice in the firm’s Washington, D.C. office and the arrival of Doreen M. Edelman (practice chair), Abbey E. Baker, Andrew Bisbas, and Megan C. Bodie. The Global Trade & Policy practice will provide U.S.-based clients, foreign clients, and foreign-owned U.S. companies with compliance and policy development services. Areas of emphasis will include import tariffs and classifications, OFAC regulations and sanctions, CFIUS review protocols, and export controls. (subscription required to access certain content)

James C. Shehan is quoted in Law360 in an article discussing the Administration’s proposed regulation forcing disclosure of drug prices in TV ads. Shehan notes that the proposal pushes the limits of existing legal authority.

StreetInsider.com, MarketWatch, RTTNews, The Advocate, Markets Insider, and Seeking Alpha highlight Lowenstein client Compassionate Care Hospice’s entering a definitive agreement to be acquired by Amedisys, Inc. (Lowenstein deal team: Marita A. Makinen, Annie Nazarian Davydov, James C. Shehan, Michael Walutes, Michael N. Gooen, Darren Goodman, Sophia Mokotoff, Jack Sidorov, and Scott Siegel.) View Lowenstein’s news announcement about this transaction.

Business Wire, Compelo Ltd., and citybizlist note Lowenstein Sandler as legal counsel to Crown Laboratories, Inc. and Hildred Capital Partners, LLC in Crown's acquisition of Bellus Medical, which will become the new Aesthetics Division of Crown Laboratories. (Lowenstein deal team led by Sam E. Khan and Herschel S. Weinstein.)

Pink Sheet quotes James C. Shehan in an article reporting pharmaceutical company Sanofi’s settlement with the U.S. Securities and Exchange Commission for violating the Foreign Corrupt Practices Act (FCPA). The article notes that this settlement follows a relatively quiet period for FCPA settlements. Shehan attributes the lack of FCPA enforcement activity to the fact that “there are fewer easy cases out there for prosecutors to go after,” that there can be a long period between the alleged violation and resolution of the case, and that companies have generally become more compliant with the law. (subscription required to access article)

In an article noting that Massachusetts-based companies accounted for nearly half of all 2017 biotech industry investments, BioPharma-Reporter reprints a quote from Steven M. Skolnick, who stated in the publication’s August 20, 2018, article that a strong market and economy have been drivers behind investments and M&A activity, leading to a large number of successful biotech IPOs.

Steven M. Skolnick is extensively quoted in BioPharma-Reporter regarding potentially record-breaking numbers in biotech initial public offerings in 2018. Skolnick notes the strong market and economy are drivers behind investments and M&A activity, leading to a large number of successful biotech IPOs. While the first half of 2018 started off strong, Skolnick cautions that the political climate and normal market indicators may cause volatility in the latter half of the year.

The Global Legal Chronicle notes Lowenstein Sandler's representation of Regulatory Professionals, Inc. (RPI) in its acquisition by Premier Research. The write-up lists the Lowenstein team: Steven E. Siesser, Lowell A. Citron, Brooke A. Gillar, Lesley P. Adamo, Eric Jesse, Alexander Brooks, Sophia Mokotoff, Megan Monson, Matthew A. Nemeth, and Sami Najib. View Lowenstein’s news announcement about this transaction.

Law360 interviews with James C. Shehan on a broad range of issues, including: critical skills for being a successful FDA lawyer, a move to streamline the FDA’s approval process, patent litigation involving biosimilars, FDA updates to off-label promotion guidance, a push in favor or competition and generics, and understanding why the FDA has reduced the number of warning and untitled letters for promotional issues. (subscription required to access article)

Law360 quotes Robert J. Kipnees and notes Kipnees and Michael A. Kaplan as counsel for the Union Mutual Medical Fund and its trustees in an article reporting the U.S. Court of Appeals for the Second Circuit’s rejection of a request by the Teamsters Local 210 Affiliated Health and Insurance Fund and its trustees that the court reconsider its June 2018 decision to uphold the trial court’s grant of summary judgment and an award of over $3.7 million on behalf of Lowenstein’s clients. View Lowenstein’s news announcement about the June 2018 appellate decision. (subscription required to access article)

The PE Hub Network, Cision PR Newswire, and FierceBiotech note Lowenstein Sandler as counsel to Regulatory Professionals, Inc. (RPI) in its acquisition by Premier Research. View Lowenstein’s news announcement about this transaction.

Law360 quotes James C. Shehan in an article discussing the likelihood of an increase in litigation against U.S. Food & Drug Administration (FDA) policies should the Hon. Brett Kavanaugh of the U.S. Court of the Appeals for the District of Columbia Circuit be confirmed to the U.S. Supreme Court. Judge Kavanaugh has criticized the Supreme Court’s Chevron doctrine, which mandates judicial deference to reasonable administrative agency interpretations of ambiguous federal laws, as enabling agencies to “stretch the meaning of statutes.” Shehan predicts that a shift by the Court on Chevron will spark more lawsuits against the FDA. He notes that while Chevron may still inspire judicial deference in cases involving complex scientific matters, any lessening of deference more generally would diminish the FDA’s authority. (subscription required to access article)

Modern Healthcare quotes James C. Shehan in an article profiling U.S. Food and Drug Administration commissioner Dr. Scott Gottlieb’s positive performance to date. Shehan states that Gottlieb is “the most prominent FDA commissioner in terms of getting out in front of the public” and that he is garnering approval from both the public and the pharmaceutical industry.

Law360 quotes Robert J. Kipnees and notes Kipnees and Michael A. Kaplan as counsel to the Union Mutual Medical Fund (UMMF) and its trustees in an article discussing UMMF’s 2^nd Circuit victory in a 10-year litigation against the Teamsters Local 210 Affiliated Health and Insurance Fund and its trustees. View Lowenstein’s news announcement about the court's decision. (subscription required to access article)

4-traders.com and StreetInsider.com note Lowenstein Sandler as legal co-counsel with Gracin & Marlow, LLP to Aravive Biologics, Inc. in connection with its merger with a wholly owned subsidiary of Versartis, Inc. in an all-stock transaction. (Lowenstein deal team: Alan Wovsaniker and Andrew E. Graw.)

The National Women's Law Center (NWLC) highlights Lowenstein Sandler as counsel in an amicus brief filed by NWLC and 40+ organizations urging the U.S. Court of Appeals for the Ninth Circuit to uphold a nationwide court order blocking two federal rules that allow corporations to deny insurance coverage for birth control.

Cosmetics Technology and Business Wire note Lowenstein Sandler as legal counsel to New Mountain Capital and portfolio company Topix Pharmaceuticals, Inc., in their acquisition of DERMA E. (Lowenstein deal team: Marita A. Makinen, David L. Goret, Matt Savare, Michael Walutes, Darren Goodman, Eric Jesse, Manali Joglekar, Marc S. Kurzweil, Kimberly E. Lomot, Justin Gindi, Tim Janas, Megan Monson, Leah Satlin, and Jacob D. Unger.)

Modern Healthcare quotes James C. Shehan, Head of Lowenstein’s FDA Regulatory Practice, on how the FDA’s new Medical Device Safety Action Plan will fill gaps in device regulation and may portend further FDA action in other areas.

Law360 quotes Lawrence M. Rolnick regarding a decision by the Delaware Chancery Court ordering Kindred Healthcare Inc. to extend or delay a stockholder vote on its proposed $4.1 billion sale to a consortium consisting of Humana Inc. and two private equity firms. Lowenstein represents Brigade Capital Management LP, an activist investor opposed to the deal.

Steven M. Skolnick and Michael Lerner are highlighted in Law360 regarding their representation of Motus GI Holdings, Inc. and its successful IPO.

Michael S. Etkin is quoted in Law360 from his argument in the pending bankruptcy case of Millennium Lab Holdings II LLC where our client, Voya Investment Management and other opt-out lenders, objected to the closing of the Chapter 11 case because of the pendency of Voya’s appeal of the confirmation order.  

James C. Shehan, Head of Lowenstein’s FDA Regulatory Practice, is quoted in Modern Healthcare regarding the security of medical devices pertaining to health systems, noting the lack of absolute security in the electronic world.

James C. Shehan comments in Law360 on the FDA’s 2017 enforcement statistics showing a continued drought of drug promotion enforcement.

In Bloomberg BNA’s Health Care Fraud Report, Scott B. McBride comments on expected trends in health care fraud cases in 2018.

Jeffrey Cohen comments in Law360 on the opposition of the amended sale order by the Official Committee of Unsecured Creditors in the Vitamin World bankruptcy proceedings.  Cohen represents the committee, which was against the delay raised over landlord issues, citing that the negotiations between the buyer and debtor’s estate had reduced the value of the assets.  

Jeffrey Cohen is quoted in Law360 regarding the proposed auction plan of Vitamin World in its Chapter 11 proceedings. Cohen represents the Official Committee of Unsecured Creditors of the vitamin and nutraceutical retailer supplement retailer.

Jeffrey Cohen is quoted in Law360 regarding concerns over the hybrid liquidation and sale plan of bankruptcy for Vitamin World. Cohen represents the Official Committee of Unsecured Creditors of the 40-year old health supplement retailer.

Michael S. Etkin is quoted in Law360 regarding his representation as bankruptcy counsel of a putative class of 2.2 million patients in connection with the 2015 data breach involving bankrupt cancer treatment center operator 21st Century Oncology that exposed their personal health information. Etkin represents the putative class of patients, which argued, among other things, that the automatic bankruptcy stay be lifted in order allow the data breach litigation pending in Florida to go forward with any recovery limited to available insurance coverage or, in the alternative, that the class proof of claim filed on behalf of the putative class be allowed to proceed in bankruptcy court.

As New Jersey Attorney General, Christopher Porrino is quoted in Reuters, NJ Spotlight, Observer, and NJ.com (among other outlets) on the state’s suits against drug companies for their role in the opioid epidemic.

As New Jersey Attorney General, Christopher Porrino is quoted on News12 New Jersey and NJ.com (among other outlets) on changes to opioid prescribing rules.

As bankruptcy counsel to lead plaintiffs in the securities litigation and the bankruptcy proceedings involving Adeptus Health Inc., Michael S. Etkin is quoted from the trial and oral arguments in Reorg Research regarding the Adeptus Health confirmation hearing. The primary confirmation issues were the standards for substantive consolidation and the impact of the U.S. Supreme Court's 2017 Jevic decision and other relevant case law on a settlement with the equity committee contained in the plan of reorganization.

In Bloomberg BNA, Scott B. McBride comments on the implications of the Supreme Court's materiality standard for False Claims Act lawsuits.

Michael S. Etkin is highlighted in Reorg Research, speaking on behalf of the proposed lead plaintiffs in the securities litigation proceedings involving Adeptus Health Inc. Etkin spoke at a status conference about his concerns regarding the announcement of an agreement between the equity committee, the unsecured creditors' committee, prepetition lender Deerfield, and the debtors.

As New Jersey Attorney General, Christopher Porrino discusses the state’s efforts to combat the rise of fentanyl in an interview with NJTV News.

In Law360, James C. Shehan opposes proposal from professors to reduce insurance coverage for accelerated approval drugs and cites good safety and effectiveness record of these products.

As New Jersey Attorney General, Chrisopher Porrino discusses the state’s tough regulations on opioid prescriptions and focus on doctors who improperly prescribe opioid painkillers in an interview with Fox News.

Jim Shehan comments in Reuters on Trump administration proposals for FDA deregulation.

In Report on Medicare Compliance, Scott McBride comments on the Department of Justice's fraud case against the former Tenet Healthcare CEO.

Jim Shehan comments in Law360 on the deluge of bold policy statements made by the FDA during the final days of the Obama administration.

In Bloomberg Law, Jim Shehan comments on the importance of maintaining contacts for GCs returning to law firms.

Jonathan L. Lewis has discussed antitrust-related issues in mergers and acquisitions with numerous prominent media outlets, including The New York Times, Forbes, Reuters, CNBC, Aviation Week Network, Business Insider, and Bloomberg.