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When Your Life Sciences Are on the Line: Protecting Your Company’s Most Valuable Asset: Trade Secrets

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When Your Life Sciences Are on the Line: Protecting Your Company’s Most Valuable Asset: Trade Secrets

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Katherine (Kate) Driscoll is a partner in Morrison Foerster’s Investigations + White Collar Defense Practice Group. Kate focuses her practice on investigations, enforcement actions, and compliance, representing companies and senior business executives. Kate has extensive experience in a wide range of criminal and civil cases, with an emphasis on pharmaceutical and life sciences clients, related to healthcare fraud, the Anti-Kickback Statute (AKS), the False Claims Act (FCA), and the Foreign Corrupt Practices Act. Kate routinely consults with clients on all manner of compliance matters, including providing risk assessments, gap analyses, and maturity evaluations. Kate also recently completed a secondment with a global consulting firm, leading government-facing investigations relating to healthcare matters.Prior to joining Morrison Foerster, Kate served as an Assistant United States Attorney in the U.S. Attorney’s Office for the Eastern District of Pennsylvania. Kate has significant trial experience, obtaining multiple jury and bench trial verdicts. As a federal prosecutor, Kate ran large-scale white-collar investigations, including complex wiretap and forensic financial investigations, involving healthcare fraud, illegal distribution of prescription drugs, money laundering, wire fraud, bank fraud, and tax fraud. Kate conducted parallel investigations with the Civil Division related to potential False Claims Act violations, and the SEC for potential violations of securities laws. Among her experience, Kate led the criminal prosecution of one of the largest theft of trade secrets cases in United States history, involving a leading multinational pharmaceutical company, and also led COVID-19-related government fraud investigations, involving the CARES Act and the Paycheck Protection Program.Kate received the 2019 Inspector General’s Award for Excellence in Fighting Fraud, Waste, and Abuse for the successful prosecution and conviction of healthcare professionals who illegally distributed millions of dollars in prescription drugs. She was also part of the prosecution team that was awarded the Prosecutor of the Year Award for 2021 from the Coalition Against Insurance Fraud regarding work on a significant arson, healthcare fraud, and tax fraud prosecution that impacted hundreds of victims and caused significant damage to the City of Philadelphia. Kate has advised and worked closely with a variety of federal and local law enforcement agencies.Kate is a lecturer at Yale University, teaching a course on white-collar investigations and prosecutions. Earlier in her career, Kate clerked for the Honorable Pamela K. Chen of the U.S. District Court Eastern District of New York. Kate earned her J.D. from the University of Pennsylvania Law School and her A.B. summa cum laude from Bryn Mawr College.<h4 dir="ltr">Representative Experience</h4>Defense Experience<ul><li dir="ltr">Represented McKinsey & Company in negotiating a $650 million five-year deferred prosecution agreement and civil False Claims Act settlement with DOJ and Corporate Integrity Agreement with HHS-OIG arising from McKinsey’s past work for opioid manufacturers, including Purdue Pharma.</li><li dir="ltr">Representation of Anthony Ornato, a former senior career civil servant who recently served as White House Deputy Chief of Staff of Operations, in the January 6 Select Committee investigation and related government investigations.</li><li dir="ltr">Representation of a multinational pharmaceutical and medical device manufacturer in various internal investigations relating to employees’ alleged kickback violations, submission of false claims, bribery, collusion with business partners, and corporate governance issues across North America.</li><li dir="ltr">Representation of a multinational holding company in a DOJ investigation arising from the client’s investment into a telehealth company under investigation for the unlawful prescription of controlled substances involving potential violations of the Controlled Substances Act (CSA) and the FCA.</li><li dir="ltr">Advising a pharmaceutical company seeking to mitigate AKS risk in supporting commercially insured patients in the transition to a new biosimilar therapy.</li><li dir="ltr">Representation of a global manufacturing company in reviewing and enhancing their anti-corruption and bribery codes of conduct, third-party due diligence protocols, and procurement policies.</li><li dir="ltr">Internal investigation in the U.S., Europe, and Latin America on behalf of a financial institution, which involved over US$1.3 billion in potential liabilities.</li></ul>Government Experience<ul><li dir="ltr">Matter involving scientists employed by a multinational pharmaceutical company who were criminally charged for conspiracy, theft of trade secrets, wire fraud, and money laundering, all relating to theft of cancer research platforms, valued at more than US$550 million.</li><li dir="ltr">Matter involving a scientist who was extradited from Switzerland after indictment for conspiracy to steal trade secrets related to the theft of research and other confidential information from several multinational pharmaceutical companies.</li><li dir="ltr">Matter involving physicians criminally charged for prescribing more than US$5 million in prescription drugs used to treat opioid addiction outside the course of professional practice and not for legitimate medical purposes.</li><li dir="ltr">Matter involving a financial advisor who was criminally charged for diversion of client funds through bank, mail, and wire fraud, and aggravated identity theft.</li><li dir="ltr">Matter involving arson that displaced hundreds of victims and injured several firefighters. Obtained convictions for all defendants and US$22 million in restitution for the victims. Brought related indictments charging additional criminal conduct, including healthcare fraud, tax fraud, and federal benefits fraud.</li></ul><h4 dir="ltr">Memberships</h4><ul><li dir="ltr">National LGBTQ+ Bar Association</li><li dir="ltr">Philadelphia LGBTQ Bar Association</li><li dir="ltr">Pennsylvania Association Criminal Defense Lawyers (Planning Committee)</li><li dir="ltr">Federal Criminal Law Committee in the Eastern District of Pennsylvania (Executive Committee)</li><li dir="ltr">University of Pennsylvania Inn of Court</li><li dir="ltr">Women’s White Collar Defense Association</li></ul>

Kate Driscoll

Partner

Nathaniel (Nate) Mendell is a partner in Morrison Foerster’s Investigations + White Collar Defense and Data, Cyber + Privacy practice groups and was the former Acting U.S. Attorney for the United States Attorney’s Office for the District of Massachusetts. He represents companies, financial institutions, boards, and executives through all phases of investigation and litigation involving allegations of corporate healthcare fraud, securities and other financial fraud, public corruption, criminal intellectual property theft, data breach or disclosure, and international money laundering. Nate leverages his two decades of service in the U.S. Department of Justice to offer clients an invaluable insider perspective on white collar defense, internal investigations, cyber breaches, and government enforcement actions.Prior to joining Morrison Foerster, Nate served as First Assistant U.S. Attorney and Senior Litigation Counsel advising the U.S. Attorney. As Acting U.S. Attorney, Nate led over 135 prosecutors and reported directly to the Attorney General. Before serving as First Assistant, Nate was Chief of the Narcotics and Money Laundering Unit, where he led more than a dozen prosecutors investigating and prosecuting money laundering cases across the United States, Colombia, Europe, and the Middle East. He also contributed to the creation of the District Court’s RISE Program and was an Assistant U.S. Attorney in the Southern District of Florida.Nate earned his B.A., cum laude, from Amherst College and earned his J.D. from Harvard Law School where he served as the Editor in Chief of the Harvard Latino Law Review.<h4>Representative Experience</h4><h5>Defense Experience</h5><ul><li>Representation of a multinational holding company in a DOJ investigation arising from the client’s investment into a telehealth company under investigation for the unlawful prescription of controlled substances involving potential violations of the Controlled Substances Act (CSA) and the False Claims Act (FCA).</li><li>Advising a pharmaceutical company seeking to mitigate Anti-Kickback Statute (AKS) risk in supporting commercially insured patients in the transition to a new biosimilar therapy. While providing support to commercially insured patients and carving out federally insured patients is not prohibited, such arrangements can draw government scrutiny if they are intended to induce or “pull through” federally insured patients to use medical services or products. We are helping formulate practical parameters for a program that will assist commercially insured patients, meet business goals, and comply with applicable laws and regulations. </li><li>Advising pharmaceutical company whose trade secrets and confidential information were used as the basis for a patent application filed by a competitor and former employees.</li><li>Advising a commercial bank on the acquisition of a medical records company under investigation by DOJ for alleged violations of the FCA.</li><li>Advising an investment management company on the acquisition of a medical device manufacturer under investigation by the DOJ for alleged violations of the FCA.</li><li>Provided training to an online market place regarding the legal framework of the AKS, recent enforcement trends, and compliance best practices.</li></ul><h5>Government Experience</h5><ul><li>Violations of the AKS against a variety of major pharmaceutical companies, which culminated in settlements involving nearly $1,000,000,000 in fines and restitution to resolve the improper use of “patient assistance programs” to subsidize patient co-pays.</li><li>Violations of the CSA against the founder and chief executive officer of a publicly‑traded pharmaceutical company related to the opioids epidemic.</li><li>FCA matters involving improper inducements, insurance pull-through schemes, and improper billing and coding practices.</li><li>Fraud and tax fraud charges against a professor suspected of stealing trade secrets and intellectual property from U.S. interests for a foreign government.</li><li>Conspiracy to obtain unauthorized access to computers and to commit wire fraud and securities fraud charges against a Russian businessman.</li><li>Charges of mail fraud, money laundering, bribery, conspiracy to commit mail and wire fraud, and racketeering conspiracy against coaches, administrators, and parents who fraudulently obtained test scores and college admissions for students related to the Varsity Blues scandal.</li><li>Six-week mail and wire fraud trial against an American businessman involved in a multi-million dollar Ponzi scheme.</li></ul>

Nathaniel R. Mendell

Jim Krenn is a corporate partner and chair of the firm’s Emerging Companies + Venture Capital Group.Jim has comprehensive experience representing emerging, growth-stage, and public companies, as well as angel, corporate, and institutional investors, in strategic transactions and corporate matters throughout the company lifecycle, from formation and early-stage financings through liquidity events and public company operations. Jim’s practice focuses on mergers and acquisitions, financings, and general corporate counseling, with a particular emphasis on life science and technology companies. He regularly advises boards of directors, executive teams, and investors on complex transactional matters, capital-raising activities, and corporate governance issues.In his mergers and acquisitions practice, Jim represents buyers and sellers in domestic and cross-border transactions across a wide range of structures, including mergers, stock and asset purchases, divestitures, joint ventures, and competitive sale processes. He has represented clients in acquisitions and sales ranging from the low millions to transactions exceeding $1 billion, for both private and public companies.Jim also counsels venture-backed and growth-stage companies in equity financings and ongoing corporate matters, and advises leading angel, corporate, and venture capital investors in their investments in such companies. He has represented clients in hundreds of venture capital and growth equity financings, from seed and early-stage rounds through $100 million-plus later-stage rounds.In addition, Jim represents public companies in initial public offerings, other capital markets transactions, and SEC reporting and compliance matters, and advises boards of directors on corporate governance issues. Jim is a member of the firm’s Life Sciences + Healthcare Group leadership team and Artificial Intelligence steering committee. He is actively involved in the startup and venture capital ecosystem, including  serving on the Board of Directors of the San Diego Entrepreneurs Exchange.<h4>Representative Transactions</h4><h5>Mergers and Acquisitions</h5><ul><li>ACEA Biosciences, a medical instruments company, in its sale to Agilent Technologies (NYSE: A) for $250 million.</li><li>Adicet Bio (Nasdaq: ACET), a biopharmaceutical company, in its merger with a wholly owned subsidiary of resTORbio (Nasdaq: TORC) to create a combined publicly traded biotechnology company.</li><li>Alaska Energy & Resources Company, a parent company of a regulated electric utility in Alaska, in its $170 million sale to Avista (NYSE: AVA).</li><li>Astute Medical, a medical diagnostic company, in its $90 million sale to bioMérieux (EPA: BIM).</li><li>B. Riley Financial (Nasdaq: RILY), a diversified financial services company, in its $53 million private placement and merger with investment banking firm B. Riley & Co.</li><li>Biotix, a private equity-backed developer and manufacturer of laboratory consumables and liquid handling solutions, in its sale to Mettler-Toledo (NYSE: MTD).</li><li>California Cryobank, a private equity-backed leader in reproductive tissue donor services and stem cell banking, in multiple acquisitions.</li><li>Clean Energy Fuels (Nasdaq: CLNE), a provider of natural gas as an alternative fuel for vehicle fleets, in its sale for up to $180 million of components of its renewable natural gas business to BP (NYSE: BP).</li><li>Cogent (Nasdaq: COGT), a biometric identification solutions provider, in its $943 million sale to 3M (NYSE: MMM).</li><li>Deere & Company (NYSE: DE), an agricultural, construction, and forestry machinery corporation, in its planned acquisition of the precision planting unit of Monsanto (NYSE: MON).</li><li>Dosatron International, a distributor of water-powered dosing pumps and systems, in connection with its sale to Ingersoll Rand (NYSE:IR).</li><li>Gillco, a leading specialty ingredient provider, in its sale to Azelis (BR: AZE).</li><li>Mentor (NYSE: MNT), a leading supplier of medical products for the global aesthetic market, in its $1.12 billion sale to Johnson & Johnson (NYSE: JNJ).</li><li>Mitchell International, a developer of smart technology solutions, in its acquisition of Cogent Works.</li><li>MyChem, a provider of ultra-pure nucleotides, in connection with its sale to Maravai (NASDAQ: MRVI) for $240 million at closing with potential additional consideration.</li><li>Protomer Technologies, a biotechnology company, in its sale to Eli Lilly and Company (NYSE: LLY) with a potential value of over $1 billion with successful achievement of future development and commercial milestones.</li><li>Rakuten Medical, a biotechnology and medical device company, in its acquisition of Medlight SA and its acquisition of key assets and manufacturing technology from Li-Cor Biosciences.</li><li>Safebuilt Insurance Services, a managing general agent and insurance technology company, in its sale to Integrated Specialty Coverages.</li><li>Sequlite Genomics, a DNA sequencing firm, in connection with its sale to Fapon Biotech, a diagnostic technology company.</li><li>Tendo, a digital health software company, in its acquisition of MDsave, a healthcare marketplace company.</li><li>Wavestream, a provider of high-power solid-state amplifiers, in its $137 million sale to Spacenet, a subsidiary of Gilat Satellite Networks (Nasdaq: GILT).</li></ul><h5>Equity Financings</h5><ul><li>9amHealth, a provider of virtual diabetes care, in its $4 million Series Seed financing and $16 million Series A financing.</li><li>ACEA Biosciences, a developer of cell analysis instrumentation technologies, in its $30 million Series E Preferred Stock financing.</li><li>Adicet Bio, a biopharmaceutical company, in its Series A financing of up to $51 million, and $80 million Series B financing.</li><li>Astute Medical, a medical diagnostic company focused on high-risk medical conditions and diseases, in over $200 million of equity and debt financings.</li><li>Bidra as an investor in multiple equity financings.</li><li>Biolumic, an agtech company, in its $13.5 million Series B financing.</li><li>California Cryobank, a private equity-backed leader in reproductive tissue donor services and stem cell banking, in multiple equity and debt financings.</li><li>Carlsmed, a medtech company pioneering AI-enabled personalized spine surgery solutions, in its $10 million Series A financing, $30 million Series B financing, $64.5 million Series C financing and $100.5 million initial public offering.</li><li>Corner Therapeutics, a biotech company, in its $54 million Series A financing.</li><li>Crinetics (Nasdaq:CRNX) as a strategic investor in Radionetics Oncology’s $52.5 million Series A financing.</li><li>Crinetics(Nasdaq:CRNX) in its $350 million PIPE financing, at-the-marketing offering of up to $350 million, $575 million underwritten public offering and $350 million underwritten public offering.</li><li>Forward Ventures as an investor in multiple equity financings, convertible debt financings, and M&A transactions.</li><li>Foxen, a provider of financial technology solutions for the real estate industry, in its $44 million Series A financing.</li><li>Greenoaks Capital Partners and its affiliates as investors in multiple equity financings, debt financings, and secondary transactions.</li><li>GroupSolver, an artificial intelligence market research platform, in multiple preferred stock financings.</li><li>Hume.ai, an artificial intelligence company, in multiple preferred stock financings.</li><li>Oak Investment Partners as an investor in multiple preferred stock financings.</li><li>OrbiMed as an investor in multiple equity financings, debt financings, and M&A transactions.</li><li>Petuum, an artificial intelligence and machine learning software infrastructure provider, in its $93 million Series B financing.</li><li>Pi Health, an AI-enabled health technology and clinical research company, in its spin-out from BeiGene, Ltd. and $35 million Series A financing.</li><li>Perceptive Advisors as an investor in multiple financings and transactions.</li><li>Presight Capital as an investor in multiple equity financings.</li><li>RA Capital as an investor in multiple equity financings.</li><li>Rakuten Medical, a biotechnology and medical device company, in over $800 million of debt and equity financings.</li><li>Rubi Laboratories, a company focused on converting carbon emissions into textiles, in multiple equity financings.</li><li>Softbank affiliates as investors in multiple equity financings.</li><li>Solarflare Communications, a technology company, in over $200 million of equity and debt financings.</li><li>Tendo Systems, a HealthTech software company, in its $20 million financing from Vistara.</li><li>Tutor Intelligence, an artificial intelligence robotics company, in its $34 million Series A financing.</li><li>VoloAgri, an ag-tech company, in over $150 million of equity financings.</li><li>Western Digital Capital as an investor in multiple preferred stock financings.</li></ul>