Keeping pace with the ever-changing life sciences industry, Morrison Foerster stays on top of the trends and political, legal, and economic drivers to support striking the balance between innovative discovery and purposeful business planning to assure our clients continued success. MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.Learn more about our <a href="https://www.mofo.com/capabilities/life-sciences-healthcare" target="_self">Life Sciences practice</a>.<h2 dir="ltr">ABOUT MORRISON FOERSTER</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. She represents clients ranging from large international pharmaceutical companies to midsized companies, startups, and universities.Meghan has filed numerous Patent Term Extension applications to secure additional term for her clients’ patents, which cover FDA-approved products. In addition, Meghan has extensive experience addressing complex obviousness-double patenting and subject matter eligibility issues impacting her clients’ patent portfolios. Meghan also represents clients in both investor-side and target-side due diligence, in deals from seed funding to initial public offerings.Prior to law school, Meghan attended graduate school at the University of California, Los Angeles, where she received a Ph.D. in biological chemistry based on her work on protein-protein and protein-DNA interactions at a molecular level. Meghan is the author of several scientific publications and has presented her research at international conferences.Meghan received her J.D. from the University of Southern California Law School and spent a year as a visiting student at Santa Clara University, where she focused on intellectual property.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants.

Meghan Poon

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in life sciences, digital, and high-tech industries.His subjects of focus include research and development collaborations, complex licensing agreements, and other technology transactions, as well as know-how protection strategies, and employee invention law. He also has substantial experience in litigating patents, trademarks, and other intellectual property assets, often in a multijurisdictional context. In addition, Wolfgang and his team frequently clear trademarks and ad campaigns and prosecute trademark applications.Wolfgang is co-editor of our <a href="https://lifesciences.mofo.com/" dir="ltr" target="_blank">MoFo Life Sciences Blog</a>.Wolfgang is a partner of Morrison Foerster based in our German office in Berlin.<h4 dir="ltr">Representative Transactional Matters</h4><ul dir="ltr"><li>U.S.-based BioTech fund on various research collaborations and other transactions with German start-ups or research institutions.</li><li>Negotiate multimillion-euro strategic partnership between two AgTech leaders concerning the development and commercialization of pest-resistant transgenic traits.</li><li>Craft global multi-million collaboration regarding AI-powered robotic MaaS.</li><li>UK-based digital health company on product roll-out of RPM applications in Germany; coordinate international expansion.</li><li>Advise numerous German start-ups on their U.S. expansion.</li><li>Draft diverse global patent and know-how license agreements in the areas of AgTech and life sciences—including gene licensing and licensing of genome editing technologies (e.g., CRISPR)—and medical devices; draft correlating supply and distribution agreements.</li><li>Structure IP rights in connection with joint ventures and other M&A transactions, including the carve-out of a patent-heavy semiconductor business comprising nine jurisdictions into a German–U.S. joint venture.</li><li dir="ltr">Advise on government-funded, multi-partner R&D projects and/or R&D projects with academic institutions, as well as on employee invention law.</li></ul><h4 dir="ltr">Representative Contentious IP Matters</h4><ul dir="ltr"><li>Lead counsel in an international dispute between software companies on rights and obligations following termination of a multi-million licensing and distribution arrangement; coordinate local counsel.</li><li>Defend Japanese chip manufacturer in high-profile SEP-litigation; advise on global settlement arrangement.</li><li>Represent leading internet retailer in patent infringement and concurrent invalidity proceedings in the context of a multijurisdictional dispute concerning touch-screen technology.</li><li>Represent diverse pharmaceutical and life sciences companies in national and cross-border patent infringement proceedings and other technology-related disputes, including preliminary injunctions as well as pre‑trial discovery and inspection proceedings, concerning, inter alia, drug-coating technologies, toner cartridges, medicinal gases, transgenic plants, and vaccines.</li><li dir="ltr">Conduct trademark, copyright, and false advertising litigation, including, most notably, a high-profile trademark litigation for a German bank, and a nine-country cross-border trademark litigation involving a famous pharmaceutical brand.</li></ul>

Dr. Wolfgang Schönig berät Mandanten zum Schutz des geistigen Eigentums sowohl in streitigen als auch nichtstreitigen Angelegenheiten, mit einem besonderen Fokus auf die IP-rechtliche Beratung von Unternehmen aus den Bereichen Life Sciences, Digitalwirtschaft und High-Tech.Zu seinen Beratungsschwerpunkten gehören Forschungs- und Entwicklungskooperationen, komplexe Lizenzvertragsgestaltungen und andereTechnologie-Transaktionen, sowie Know-how-Schutz-Strategien und das Arbeitnehmererfinderrecht. Er verfügt zudem über umfangreiche Prozesserfahrung zur Durchsetzung von Patenten, Marken- und anderen IP-Rechten, häufig auch in einem grenzüberschreitenden Kontext. Darüber hinaus bewertet Dr. Wolfgang Schönig zusammen mit seinem Team regelmäßig die Rechtskonformität von Werbekampagnen, prüft die Verfügbarkeit von Marken und entwickelt entsprechende Anmeldestrategien.Dr. Wolfgang Schönig ist Co-Editor des Life Sciences Blogs von Morrison Foerster.Er hat seinen Doktortitel an der Heinrich-Heine-Universität Düsseldorf und seinen LL.M. an der Fordham School of Law in New York erworben, jeweils mit Schwerpunkt im gewerblichen Rechtsschutz. Seinen MBA-Abschluss erhielt er von der European University in Barcelona.Dr. Wolfgang Schönig ist Partner des deutschen Büros von Morrison Foerster in Berlin.<h4 dir="ltr">Repräsentative Transaktionen</h4><ul><li dir="ltr">BioTech-Fonds mit Sitz in den USA bei verschiedenen Forschungskooperationen und anderen Transaktionen mit deutschen Start-ups oder Forschungseinrichtungen</li><li dir="ltr">Verhandlung einer hochvolumigen strategischen Partnerschaft zwischen zwei Technologieführern im Bereich Crop Science betreffend der Entwicklung und Kommerzialisierung von bestimmten Resistenzen</li><li dir="ltr">Gestaltung einer globalen Multi-Millionen-Zusammenarbeit für KI-gestützte Roboter</li><li dir="ltr">Ein in Großbritannien ansässiges Unternehmen für digitale Gesundheit bei der Markteinführung von RPM-Anwendungen in Deutschland; Koordination der internationalen Expansion</li><li dir="ltr">Beratung zahlreicher deutscher Start-ups bei deren US-Expansion</li><li dir="ltr">Strukturierung und Verhandlung diverser Patent- und Know-How-Lizenzen in den Bereichen Ag Tech und Life Sciences – einschließlich Fragen zu genome editing wie CRISPR-Medizingeräte, sowie Gestaltung von Softwarelizenzverträgen und Erstellung korrespondierender Liefer- und Vertriebsvereinbarungen</li><li dir="ltr">Strukturierung von IP-Rechten im Zusammenhang mit Joint Ventures und anderen M&A-Transaktionen, darunter die Koordination eines neun Länder umfassenden IP Carve-Outs im Rahmen eines Halbleiter-JVs</li><li dir="ltr">Beratung zu staatlich geförderten Multi-Partner F&E-Projekten und/oder F&E-Projekten mit akademischen Einrichtungen sowie zum Arbeitnehmererfindungsrecht</li></ul><h4 dir="ltr">Repräsentative IP-Streitigkeiten</h4><ul><li dir="ltr">Lead Counsel in einem internationalen Rechtsstreit zwischen Softwareunternehmen über Rechte und Pflichten nach Beendigung einer millionenschweren Lizenz- und Vertriebsvereinbarung; Koordinierung der lokalen Anwälte</li><li dir="ltr">Verteidigung eines japanischen Chipherstellers in einem prominenten Streitfall bezüglich Standardessentieller Patente (SEP); Beratung zu einer globalen Vergleichsregelung</li><li dir="ltr">Verteidigung einer führenden Internetplattform gegen Ansprüche eines Patenttrolls wegen vermeintlicher Verletzung von Patent bezüglich Touchscreen-Technologie sowie korrespondierende US-Streitigkeiten</li><li dir="ltr">Vertretung von Pharma- und Life Science-Unternehmen in nationalen und grenzüberschreitenden Patentverletzungsverfahren und anderen technologiebezogenen Streitigkeiten, einschließlich einstweiliger Verfügungsverfahren und vorprozessualer Beweissicherungs- und Besichtigungsverfahren, unter anderem in Bezug auf Arzneimittelbeschichtungstechnologien, Tonerkartuschen, medizinische Gase, transgene Pflanzen und Impfstoffe</li></ul>

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Wolfgang Schönig is a partner of Morrison Foerster (International) LLP based in our German office in Berlin. His practice specialty is advising on IP aspects relative to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. Wolfgang is specialized in research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig focuses his practice on IP aspects relative to transactions in the digital, telecoms, high tech, life sciences, and pharmaceuticals industry, as well as legal representation in IP disputes.

Wolfgang Schönig advises clients on IP aspects relating to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. His additional focus areas include research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig

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During the COVID-19 pandemic, governments across the globe have become increasingly involved in the private sector.[1] State-owned enterprises have long been common in Asia, but the pandemic has increased their prominence in Europe. In Italy and Norway, for instance, governments are taking equity stakes in the airline industry to help distressed companies. Now, with vaccine manufacturing ramping up, it makes sense that governments would intervene in the life sciences and pharmaceutical sectors as well. In our article published earlier this month on, we analyzed the <a target="_blank" href="https://lifesciences.mofo.com/topics/COVID-19-State-Intervention-in-Times-of-Vaccine-Shortages.html">legal framework for state intervention in vaccine production in Germany</a>. Since then, the German government has <a target="_blank" href="https://www.reuters.com/article/health-coronavirus-vaccine-supply-insigh/as-vaccine-nationalism-deepens-governments-pay-to-bring-production-home-idUSKBN2B40IX">increased its support </a>for local vaccine production. But what is happening across the pond in the United States?Here, too, the federal government has intervened to ramp up the vaccine supply. On March 2, 2021, President Biden announced an historic partnership between Johnson & Johnson (J&J) and Merck to increase production of J&J’s COVID-19 vaccine. While this partnership between two pharmaceutical behemoths is significant in its own right, it also made headlines for the role government played in brokering the deal. The Biden administration agreed to pay $268.8 million to upgrade two Merck production facilities and is helping Merck procure necessary equipment. Of course, this was not the first time during the Coronavirus crisis that the federal government has intervened to shape the private sector’s pandemic response.[2] Nevertheless, it is notable that President Biden is engaging the private sector at this scale and so soon into his presidency. The Biden administration’s early approach to state intervention during the COVID-19 pandemic may portend even greater involvement down the road, which would present both opportunities and risks for life sciences companies doing business in the U.S.<h4>The Statutory Framework</h4>Over 90 percent of constitutions in the world contain emergency clauses, but not the U.S. Constitution.[3] Instead, the federal government’s authority to intervene in a pandemic comes from a patchwork of statutes and regulations. At the center of this constellation is the Defense Production Act, 50 U.S.C. § 501 et seq. (DPA). The origins of the DPA trace back to the War Powers Act of 1941 and 1942, passed during WW2 to give President Roosevelt more control over the wartime economy. Congress enacted the DPA in 1950 during the Korean War and has re-authorized it ever since then—most recently in the John S. McCain National Defense Authorization Act of 2019. In short, the modern DPA authorizes the executive branch to mobilize private actors and allocate resources during moments of national crisis. The president can compel companies to prioritize orders from the government, allocate materials/resources, offer loans or loan guarantees, make purchase commitments, and authorize companies to work together. Historically, the federal government has used the DPA to procure defense contracts and respond to natural disasters. For more information about the DPA, see MoFo’s articles providing a <a target="_blank" href="https://govcon.mofo.com/coronavirus/a-summary-of-the-defense-production-act/">summary of the Defense Production Act</a> and <a target="_blank" href="https://govcon.mofo.com/coronavirus/the-defense-production-act-a-little-known-statute-that-may-soon-be-running-your-company/">three key takeaways about the DPA</a>. In addition to the DPA, the executive branch derives authority to respond to public health emergencies from several other sources. First, the National Emergencies Act, 50 U.S.C. § 1601 et seq., allows the president to declare national emergencies, which essentially unlock statutory powers that the executive branch cannot otherwise access. President Trump declared the COVID-19 pandemic a national emergency on March 13, 2020. Second, the Stafford Act, 42 U.S.C. § 5521 et seq., organizes federal emergency assistance with respect to state and local governments. Third, the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, 42 U.S.C. ch. 6A § 201 et seq., allows the Food & Drug Administration (FDA) to prepare and stockpile medical countermeasures (drugs, vaccines, and devices), and streamlines the FDA’s emergency responsiveness. Fourth and most recently, the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) gives the FDA a greater role in drug/vaccine supply chains. This is not an exhaustive list of emergency legislation. But when it comes to intervening in private contracting to boost vaccine production, the DPA is the most significant legislation.<h4>The Biden Administration’s Response to COVID-19</h4>On his very first day in office, President Biden passed Executive Order 13987. E.O. 13987 established the position of Coordinator of the COVID-19 Response (currently Jeffrey Zients) and organized that office in the White House. Among other responsibilities, President Biden charged the COVID-19 Response Coordinator with coordinating the government’s efforts to produce and distribute personal protective equipment, vaccines, and tests, “including through the use of the Defense Production Act[.]”[4] President Trump depended somewhat on the DPA for his early COVID-19 response, but critics, including then-candidate Biden, argued that he did not fully take advantage of the <a target="_blank" href="https://www.nytimes.com/2020/09/22/health/Covid-Trump-Defense-Production-Act.html">Act to manage the medical equipment supply chain</a>. Thus, President Biden’s early focus on the DPA signaled a shift from the prior administration.The next day, on January 21, 2021, President Biden signed Executive Order 14001, ordering the secretary of state, secretary of defense, secretary of health and human services, secretary of homeland security, and the heads of relevant agencies to review the inventory of critical pandemic response supplies and fill any shortfalls. In particular, section 2 of the E.O. directs executive officers to “take appropriate action using all available legal authorities, including the Defense Production Act, to fill those shortfalls as soon as practicable by acquiring additional stockpiles, improving distribution systems, building market capacity, or expanding the industrial base.”[5] Section 3 lays out steps to address the pricing of pandemic supplies. Section 4 seeks to develop “a strategy to design, build, and sustain a long-term capability in the United States to manufacture supplies for future pandemics and biological threats.” Section 5 provides that the federal government will communicate with Tribal governments to ensure access to the Strategic National Stockpile.The Biden administration <a target="_blank" href="https://www.politico.com/news/2021/02/05/biden-defense-production-act-coronavirus-466130">announced its first significant anti-COVID-19 measures</a> on February 5, 2021. Specifically, it announced plans to sign DPA contracts with six diagnostic companies to make at-home and point-of-care testing more widely available. It also announced that it would use the DPA to give Pfizer priority access to certain materials that are essential in vaccine manufacturing. At that time, the FDA had only approved the Pfizer and Moderna vaccines, while the J&J single-shot vaccine was still under review. The White House expected J&J to get FDA approval, but <a target="_blank" href="https://www.politico.com/news/2021/02/05/biden-defense-production-act-coronavirus-466130">under-produce in terms of quantity</a>. Of course, the Biden administration later addressed that shortfall when it facilitated the J&J-Merck partnership.<h4>Opportunities for Collaboration Among Private Actors</h4>Given President Biden’s early reliance on the DPA within the first 60 days of his presidency, it is likely that the federal government will continue to intervene in private contracting. This is exciting for life sciences companies because government purchase orders and loan guarantees can provide businesses with reliable revenue streams. Moreover, the DPA may create unique opportunities for businesses to collaborate that might not otherwise be possible. Most notably, Section 708 of the DPA provides for voluntary agreements among private parties to meet national defense requirements or needs. Section 708(j) creates a limited defense to antitrust enforcement if anticompetitive behavior was done “in the course of developing a voluntary agreement initiated by the President or a plan of action adopted under any such agreement [or] to carry out a voluntary agreement initiated by the President and approved in accordance with this section[.]” In other words, collaboration between competitors, such as J&J and Merck, does not risk antitrust enforcement when it has the president’s seal of approval. And while subsection (j) requires the president to initiate voluntary agreements, there is little antitrust risk if entities pitch these agreements to the White House. Thus, the DPA may create new opportunities for businesses during COVID-19.Yet would-be collaborators should still be wary of antitrust risks. In April 2020, MoFo antitrust lawyers published an <a target="_blank" href="https://www.corporatecomplianceinsights.com/collaboration-pricing-covid-19/">article highlighting several antitrust risks</a> specific to the COVID-19 pandemic. They warned that the Department of Justice and Federal Trade Commission will still go after anticompetitive behavior, especially behavior that seeks to take advantage of the ongoing pandemic such as price gouging, price fixing, and stockpiling/hoarding resources. The article also highlighted possible consumer protection issues related to COVID-19. For instance, consumer protection laws in many states also proscribe price gouging. And although the DPA provides a <a target="_blank" href="https://fas.org/sgp/crs/natsec/LSB10534.pdf">limited defense with respect to antitrust enforcement</a>, it is not clear that subsection (j) applies to consumer protection laws as well. Ultimately, businesses hoping to collaborate with pandemic responsiveness/vaccine production should be cautious and seek counsel.<h4>The Outlook for Late 2021 and Beyond</h4>President Biden’s intervention to ramp up vaccine production has been an unqualified success. Entering office, his goal was to provide 100 million vaccinations within his first 100 days. After reaching that target on day 59, President Biden announced a bold, new goal: 200 million vaccinations within the first 100 days. Given that there are 260 million adults living in the U.S., that is good news; experts predict that approximately <a target="_blank" href="https://www.nytimes.com/live/2021/03/25/world/covid-vaccine-coronavirus-cases">80 percent of the population, or 208 million, must be vaccinated to achieve herd immunity</a>. Altogether, the Biden administration hopes to make vaccines available to <a target="_blank" href="https://www.nytimes.com/2021/03/02/us/politics/merck-johnson-johnson-vaccine.html">every adult in the United States by May 1</a>.Yet that will not mark the end of vaccine production in the United States. First, as new variants of the coronavirus emerge over the summer, vaccinated individuals may require <a target="_blank" href="https://www.npr.org/sections/health-shots/2021/02/25/971345409/covid-19-vaccine-makers-booster-shots-aim-at-a-moving-target-coronavirus-variant.">booster shots</a> to keep up their immunity. Fortunately, Pfizer and Moderna have already started preparing to bring variant-specific third doses to clinical trial. Second, the FDA is likely to approve COVID-19 vaccines for children at some point in the future. To date, the FDA has only approved vaccines for adults. Just last week, however, Pfizer announced a <a target="_blank" href="https://www.cnbc.com/2021/03/25/covid-vaccine-pfizer-begins-trial-on-infants-and-young-kids.html">clinical trial for its COVID-19 vaccine involving healthy 6-month-old to 11-year-old children</a>. With over 70 million children living in the U.S., it is likely that demand for the COVID-19 vaccines will remain high through the end of 2021. Third, the U.S. will remain involved in vaccine production even after reaching domestic herd immunity. Soon after entering office, President Biden entered <a target="_blank" href="https://www.bbc.com/news/world-55795297">Covax</a>, a partnership with the World Health Organization to deliver COVID-19 vaccines to the developing world. Low- to middle-income countries lag behind wealthy nations in terms of vaccine procurement, and current models estimate that there will not be enough vaccines for the global population until 2023–24.What exactly does all of this mean for life sciences companies doing business in the United States? It means that, although there appears to be a light at the end of the COVID-19 tunnel, the pandemic will continue to unfold both domestically and abroad well into the future. Correspondingly, private-public partnerships and state interventions into vaccine production should persist into the future as well. Businesses that are currently fighting COVID-19 should brace themselves to continue long-term. And businesses that have not been involved with the pandemic response thus far may yet find opportunities to contribute going forward.<h4>Short-Term Authority and Long-Term Preparedness</h4>Looking beyond COVID-19 vaccine production and rollout, the DPA will also play a prominent role in general pandemic preparedness going forward. Again, E.O. 14001 sought to increase vaccine production capacity for future pandemics. On the surface, it may seem odd that the president could wield emergency powers to achieve long-term objectives. Yet the DPA actually contemplates such prophylactic measures; in fact, preparedness is one of the primary objectives of the policy.[6] Of course, life sciences companies may not be able to produce vaccines in anticipation the next deadly virus outbreak, but they can begin to replenish the national stockpile of personal protective equipment and medical devices, such as ventilators. Already, President Biden has used <a target="_blank" href="https://www.wsj.com/articles/biden-to-address-chip-shortages-supply-chain-problems-with-executive-action-11614160803">executive authority to bolster supply chains</a> for critical pharmaceutical materials. Look out for similar measures in the future.Over one year into COVID-19, even with vaccines rolling out across the country, there is still a long way to go in responding to this pandemic and preparing for the next one. And while the Biden administration is still in its infancy, it is already clear that the White House will take a hands-on approach in public health and emergency preparedness—before, during, and after crises. Healthcare and life sciences companies should prepare for—and look forward to—that new reality.[1] OECD Policy Responses to Coronavirus (COVID-19)The COVID-19 crisis and state ownership in the economy: Issues and policy considerations. The Wall Street Journal: <a target="_blank" href="https://www.wsj.com/articles/western-economies-embrace-state-intervention-emulating-asia-11604574001">Western Economies Embrace State Intervention, Emulating Asia</a>.[2] <a target="_blank" href="https://www.lawfareblog.com/understanding-trumps-invocation-defense-production-act-meat">Understanding Trump’s Invocation of the Defense Production Act for Meat</a>.[3] Harvard Law Review: States of Emergencies Part I. Oxford Academic: <a target="_blank" href="https://academic.oup.com/icon/article/16/1/101/4995561?login=true">The architecture of emergency constitutions</a>.[4] Federal Register: <a target="_blank" href="https://www.federalregister.gov/documents/2021/01/25/2021-01759/organizing-and-mobilizing-the-united-states-government-to-provide-a-unified-and-effective-response">Organizing and Mobilizing the United States Government To Provide a Unified and Effective Response To Combat COVID-19 and To Provide United States Leadership on Global Health and Security</a>.[5] Federal Register: <a target="_blank" href="https://www.federalregister.gov/documents/2021/01/26/2021-01865/a-sustainable-public-health-supply-chain">A Sustainable Public Health Supply Chain</a>.[6] The Stafford Act defines “emergency preparedness” to include “[m]easures to be undertaken in preparation for anticipated hazards[.]” 42 U.S.C. § 5195a(3)(A).

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid DeCoursey Bondoc

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid Bondoc

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Vaccine Production and State Intervention in the U.S.

Using Waivers to Curb COVID-19 Legal Exposure

During the COVID-19 pandemic, governments across the globe have become increasingly involved in the private sector.[1] State-owned enterprises have long been co

Vaccine Production and State Intervention in the U.S.

U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory oversight. The FDA recently published an AI/ML SaMD action plan, developed in direct response to stakeholder feedback. It is now one month later, and the FDA has yet to implement any steps outlined in its action plan, all the while approving more and more AI products. This post discusses the progress the FDA has made thus far for regulating AI/ML-based SaMDs and the concerns that remain.<h4>FDA’s Progress for Regulatory Oversight</h4>Artificial intelligence is growing rapidly in the field of healthcare. The <a target="_blank" href="https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device">FDA has acknowledged</a> its importance and the impact it has on health care, but has not been able to keep up with manufacturers. In April 2019, the FDA published “<a target="_blank" href="https://www.fda.gov/files/medical%20devices/published/US-FDA-Artificial-Intelligence-and-Machine-Learning-Discussion-Paper.pdf">Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback</a>,” describing for the first time, clearly, the FDA’s potential approach to premarket review of AI/ML SaMDs. The potential approach involved a “Predetermined Change Control Plan” for premarket submissions including “SaMD Pre‑Specifications” (SPS) and an “Algorithm Change Protocol” (ACP) to account for the iterative nature of AI/ML-based SaMDs.In February 2020, the FDA announced a marketing authorization via the De Novo pathway for the <a target="_blank" href="https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-cardiac-ultrasound-software-uses-artificial-intelligence-guide-user">first cardiac ultrasonic software that uses AI to guide users</a>. The manufacturer used a Predetermined Change Control Plan in its application to obtain authorization.In the same month, the FDA held a public workshop on the “Evolving Role of Artificial Intelligence in Radiological Imaging.” The FDA and the public stakeholders discussed best practices for validation of AI‑automated radiological imaging software and image acquisition devices.In September 2020, FDA launched the <a target="_blank" href="https://www.fda.gov/news-events/press-announcements/fda-launches-digital-health-center-excellence">Digital Health Center of Excellence</a> within the Center for Devices and Radiological Health. According to the FDA, the focus of the Digital Health Center of Excellence is “helping both internal and external stakeholders achieve their goals of getting high quality digital health technologies to patients by providing technological advice, coordinating and supporting work being done across the FDA, advancing best practices, and reimaging digital health device oversight.”In January 2021, the FDA published “<a target="_blank" href="https://www.fda.gov/news-events/press-announcements/fda-releases-artificial-intelligencemachine-learning-action-plan">Artificial Intelligence/Machine Learning (AI/ML)‑Based Software as a Medical Device (SaMD) Action Plan</a>,” outlining the FDA’s plans for progressing its regulatory oversight. The Action Plan identified five areas for the FDA focus: <ol><li>Tailored regulatory framework for AI/ML-based SaMDs; </li><li>Good machine learning practices (GMLPs); </li><li>Patient-centered approach incorporating transparency to users; </li><li>Regulatory science methods related to algorithm bias and robustness; and </li><li>Real-world performance (RWP).  </li></ol>The FDA stated that it will update its regulatory framework and publish a draft guidance in 2021, actively engage in efforts to harmonize GMLPs, hold public workshops on device labeling for transparency to users, develop methodology for evaluating and improving machine learning algorithms (including identifying and eliminating bias), and develop a framework for gathering and validating RWP. Although the AI/ML Action Plan is recent, the FDA has not yet taken any steps to implement any of these focus areas for policy development or clarification.<h4>The FDA’s Approval of AI/ML-Based SaMDs</h4>Since 2012, the FDA has approved over 160 medical AI/ML-based SaMDs, the majority being in 2019 and 2020. Some <a target="_blank" href="https://www.statnews.com/2021/02/03/fda-artificial-intelligence-clearance-products/">reports</a> have found, upon investigation, that the requirements the FDA has imposed on device submission have been inconsistent. For example, some submission sponsors disclosed the amount of patient data used to validate the performance of their devices while others did not. And, according to one investigative <a target="_blank" href="https://www.statnews.com/2021/02/03/fda-clearances-artificial-intelligence-data/">report</a>, when disclosed, the amount of data varied widely from 100 patients on one end of the spectrum to 15,000 patients on the other end. Only a handful of manufacturers reported racial makeup of the study populations and a few provided gender breakdown. This creates uncertainty as to how effective the AI/ML-based SaMDs will perform with respect to algorithmic bias. Additionally, the FDA has not made training and testing data for these approved AI/ML-based SaMDs publicly available, potentially creating a lack of trust in these technologies or, at the very least, making it difficult for purchasers of the SaMDs to make informed decisions based on similar evidence criteria. However, perhaps most importantly, the FDA has yet to figure out how to handle real-world leaning and adaptation within the regulatory framework. Although the FDA clearly aims for increased regulation and monitoring of AI/ML-based SaMDs, it has not provided a specific plan for any of the five focus areas identified in its AI/ML Action Plan. The FDA may need to act much quicker in developing consistent standards as the number of AI/ML-based SaMDs submissions to the FDA continue to increase (from two products in 2012 to 70 products in 2019). The FDA should address stakeholder concerns of data and approval process inconsistencies, lack of well-established standards, transparency, labeling challenges, trustworthiness, algorithmic biases, and RWP. ConclusionThe FDA is slowly taking steps towards its commitment to develop a regulatory framework for AI/ML-based SaMDs. For now, the FDA has not yet provided any consistent standards. Without such widely-applicable guidance, manufacturers should expect a longer application timeline and extensive discussions with the FDA—in effect creating a customized plan for data and evidence generation for each and every AI/ML SaMD. It is unpredictable at this stage what the FDA will require and ask for in these negotiations, although to some extent prior submissions and authorizations serve as a baseline for consideration. As artificial intelligence and machine learning technologies are increasing in availability and applicability, organizations and device sponsors will continue to build their own databases and define their own standards, which the FDA may be strategically waiting for.

Round Rock Research, LLC v. [Multiple Defendants]

Sage Electrochromics, Inc. v. View, Inc.&nbsp;

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Of Counsel

A former lead engineer at the NASA Jet Propulsion Laboratory, Dr. Nguyen focuses her practice on domestic and international patent prosecution. She is a founder and co-leader of the firm’s Life Scienc

Jean Nguyen Ph.D.

Jean Nguyen

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FDA’S PLAN FOR AI/ML-BASED SOFTWARE AS MEDICAL DEVICES: PROGRESS AND CONCERNS

Patenting Artificial Intelligence in the U.S. – Considerations for AI Companies

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U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (S

FDA’S PLAN FOR AI/ML-BASED SOFTWARE AS MEDICAL DEVICES: PROGRESS AND CONCERNS

Session 11 of the GSAS Harvard Biotech Club and Morrison & Foerster course on <a href="https://www.mofo.com/resources/events/201111-legal-topics-scientists.html" target="_blank">Legal Topics for Scientists, Entrepreneurs, and Start Ups</a> was led by <a href="https://www.mofo.com/capabilities/life-sciences-transactions-licensing.html" target="_blank">Life Sciences Transactions + Licensing</a> partner <a target="_blank" href="http://www.mofo.com/people/wolfgang-schonig.html">Wolfgang Schoenig</a> focusing on key EU Intellectual Property. Wolfgang discussed Intellectual Property Rights, GMOs, and Employee inventors’ rights in the EU sharing that "it was fun to highlight some of the starkest differences between the U.S. and EU when it comes to patentable subject matter, policies around GMO, and inventor remuneration to such a talented group of researchers and entrepreneurs."<a href="https://www.mofo.com/capabilities/patent-litigation.html" target="_blank">IP Litigation</a> partner <a href="https://www.mofo.com/people/mark-whitaker.html" target="_blank">Mark Whitaker</a> followed in session 12, providing a trade secrets overview and best practices including strategies for reviewing specific trade secrets and how to protect trade secrets overseas involving the ITC. Mark commented that "a thorough knowledge of federal, state, and international trade secrets laws, directives, and best practices is critical for inventors, entrepreneurs, and companies to adequately protect their intellectual property regardless of where they sit in the development life cycle. I hope that our session raised the participants’ awareness of these indispensable tools."This Wednesday, we’ll turn to Plant Intellectual Property Protection with <a target="_blank" href="https://www.mofo.com/people/cory-ellison.html">Cory Ellison</a>.

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in the digital, high-tech, life sciences, and pharmaceutical industries.

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Mark Whitaker is co-chair of the firm’s Intellectual Property Litigation Practice and has more than 30 years of experience crafting legal strategies in high-stakes patent and trade secret litigation.

Mark Whitaker

Mark’s clients benefit from his more than 29 years of experience as a trial lawyer, crafting litigation strategies in high-stakes patent and trade secret litigation. Mark sees the whole board for each of his clients, and works closely with them to define a successful litigation outcome, and determine the best path to achieve that goal.

Mark L. Whitaker

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Key EU Intellectual Property and Trade Secrets

GSAS Harvard Biotech Club and Morrison & Foerster’s Patent Course Off to a Roaring Start!

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Session 11 of the GSAS Harvard Biotech Club and Morrison & Foerster course on Legal Topics for Scientists, Entrepreneurs, and Start Ups was led by Life Sciences

Key EU Intellectual Property and Trade Secrets

On January 28, 2021, the United States’ Department of Justice (DOJ) announced an $18.25 million <a target="_blank" href="https://www.justice.gov/opa/press-release/file/1361441/download">settlement</a> with athenahealth Inc. (“Athena”) to resolve allegations that Athena violated the False Claims Act by paying impermissible kickbacks related to its electronic health records (EHR) product. At the center of the DOJ’s complaint was Athena’s use of three different marketing programs, which the DOJ alleges violated the False Claims Act and the Anti-Kickback Statute.<h4>Marketing Programs</h4>In its complaint, the DOJ highlighted three of Athena’s marketing programs, all of which allegedly incentivized the use of Athena’s EHR product in return for cash payments or other luxury amenities. In its “Concierge Events” program, Athena provided key decision-makers at current clients and potential new clients with tickets, travel, and luxury accommodations to events such as the Kentucky Derby and the Masters golf tournament. In a second marketing program, Athena implemented a “Lead Generation” program to find new customers, which provided existing customers with direct payments that varied based on the volume and value of business generated for Athena’s services. In a third marketing program, Athena entered into “Conversion Deals” with competitors that were going out of business. Athena paid these competitors based on the volume and value of the health care practices that the competitor was able to refer and convert from the competitor to Athena’s product.<h4>Compliance Program</h4>DOJ contended that Athena implemented these programs despite having policies and procedures in place that barred the payment of kickbacks and business payments, including a specific policy prohibiting gifts that were “likely or intended to influence a specific decision or deal.” The DOJ’s complaint also alleges that Athena’s internal documents acknowledged the issues with the Concierge Events program. In particular, internal documents referenced recruitment challenges because invitees’ compliance issues would prevent the invitees from accepting an invitation. Further, the DOJ alleges that due to its previous settlement with another EHR vendor due to that vendor’s impermissible referral program, Athena had actual knowledge that its referral program was also impermissible, given the substantial similarities.The DOJ’s action here shows that it is not enough for companies to have policies and procedures in place, but rather a company’s actions must match what is set forth in its compliance program. Similarly, companies need to be aware of DOJ enforcement actions and adjust their practices in the event the DOJ finds that a similar program violates the Anti-Kickback Statute.<h4>Alleged Anti-Kickback Statute and False Claims Act Violations</h4>The DOJ alleges that the marketing programs described above constituted illegal remuneration under the Anti-Kickback Statute. In turn, these illegal payments caused Athena’s health care provider customers to submit millions of dollars of false claims for payment to Medicare and Medicaid under the Health Information Technology for Economic and Clinical Health Act’s (HITECH) electronic health record incentive program, later replaced by the Merit-based Incentive Payment System (MIPS).<h4>Other EHR DOJ Settlements</h4>This settlement comes on the heels of last year’s $145 million resolution with Practice Fusion, Inc., to resolve criminal and civil investigations related to its EHR software. In that arrangement, Practice Fusion received impermissible kickbacks from pharmaceutical companies in exchange for implementing clinical decision support alerts in its software that prompted health care providers to prescribe the pharmaceutical companies’ drug products. Together, these DOJ actions show that the DOJ will continue to crack down on the provision of incentives that influence health care providers’ decision-making.

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EHR Vendor Settles Kickback Allegations to the Tune of $18.25 Million

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On January 28, 2021, the United States’ Department of Justice (DOJ) announced an $18.25 million settlement with athenahealth Inc. (“Athena”) to resolve allegati

EHR Vendor Settles Kickback Allegations to the Tune of $18.25 Million

Sponsored Research Agreements (SRA) are used by companies to contract a research organization, such as a university, to conduct research and development activities in exchange for fees and the university’s rights to use the results for general research purposes. Care should be taken to ensure intellectual property (IP) of the sponsoring company (Sponsor) is properly secured. In this latest edition of <a href="https://www.mofo.com/capabilities/life-sciences-transactions-licensing.html" target="_blank">MoFo’s Life Sciences Transactions + Licensing</a> Top 10, we provide a list and explanation of our top 10 issues to consider when drafting and negotiating SRAs with universities, and we cover some of the distinctions that arise under U.S., EU, and German law.1. CONSIDER A LIMITED LICENSE GRANT TO SPONSOR’S BACKGROUND IPA research partner may need access to the Sponsor’s background IP to conduct the research and development activities that are the subject matter of the project to which the SRA relates. The Sponsor should consider limiting any license to Sponsor’s background IP to include the IP necessary for the research partner to conduct the research and development pursuant to the SRA for the benefit of the Sponsor. Sponsors frequently limit any such license in both scope and duration, solely for the performance of the services to be provided by the research partner, consistent with the scope of the project, and pursuant to the terms of the SRA. Any license to Sponsor’s background IP is commonly non-exclusive to avoid interference with the Sponsor’s and its other licensees’ use of the licensed IP.Sponsors should also consider obtaining a present assignment of all improvements to its background IP that the research partner creates (either solely or in conjunction with the Sponsor) during the term of the SRA. Since a patent does not grant a patent holder any right to improvements, without an assignment, care should be taken to ensure that the research partner is prevented from blocking the Sponsor from practicing an improvement to its invention. When drafting the applicable assignment, it is critical that the assignment clause includes language that will be enforced to ensure automatic assignment to the Sponsor of all future interests in the improvements at the time of its creation. The phrase “hereby assigns in advance” is commonly appropriate, depending on the applicable circumstances.2. ALLOCATING PROJECT IP CAN BE CHALLENGINGA Sponsor may request complete ownership of the new intellectual property developed during the research project (commonly referred to as foreground IP). Unless the SRA is a services agreement, research partners commonly push back and seek to assert ownership rights to foreground IP. This is particularly true if the research partner is a university because it may want the public to have access to the IP, if the research is partially funded by the government or if the foreground IP is developed based upon the research partner’s background IP.As a consideration for the Sponsor’s ownership of foreground IP, the research partner may ask for a license to use foreground IP for its own research and non-commercial purposes. It’s also true that research licenses may be mandatory in sponsored research projects conducted in the EU due to antitrust laws. Attention should be paid to the language of such research license to ensure that it does not interfere with the Sponsor’s right to grant licenses in the future and, to the extent admissible, that it excludes any direct or indirect commercial use. When universities require ownership of foreground IP, Sponsors commonly seek an exclusive license to use and commercialize the foreground IP. If further concessions need to be made to the research partner, exclusivity can be limited to specific field of use. In any license scenario, Sponsors should pay close attention to diligence requirements associated with licenses from research partners. These provisions often provide a step down from exclusivity to non-exclusivity or, eventually, a termination of the license, if the Sponsor neglects to use the foreground IP or fails to meet certain milestones.Sponsors and research partners may also consider joint ownership of foreground IP. Joint ownership provisions need to be carefully crafted to address the type of IP involved and the abundantly different requirements for joint ownership in various jurisdictions. For example, whereas in the United States each patent co-owner can freely grant licenses to third parties without a duty to account, under German law, a license will generally require the consent of the co-owner and may involve sharing of proceeds. While often complex and heavily negotiated, joint ownership of foreground IP is an option for Sponsors and research partners.Finally, Sponsors must also obtain adequate access to the research partner’s background IP, if contained in the research results or otherwise necessary to use research results or any of the foreground IP, in order to avoid being blocked from use and exploitation.3. BEWARE OF THE LIMITATIONS ON FEDERALLY FUNDED RESEARCH AND STATE AID LAWSIn the United States—and even more so in the EU—research institutes, like universities, are often state owned or state funded. Public funding and additional restrictions and obligations in an SRA commonly go hand-in-hand.In the United States, if the research is partly funded by the federal government, the Sponsor should be aware of the restrictions and the federal government’s rights to the resulting inventions and its university partner under the Bayh-Dole Act, which is the federal legislation that permits ownership of patents resulting from federally funded research to remain with inventors and their employers. One particular restriction to note, inventions resulting from the project will have to be manufactured substantially within the United States. Furthermore, the funding federal agency will have a nonexclusive license to the research inventions and the “march-in rights” to grant a third party an exclusive or non-exclusive license if the university does not take reasonable steps to use or commercialize the inventions or if the inventions will not be manufactured substantially in the United States.If the research does not require government funding, the Sponsor should obtain a representation from the university that the university will not use any government funding for the research. If government funding is necessary, SRAs commonly include a mechanism to separate the government-funded research from the research funded entirely by the Sponsor.In the EU, to the extent patentable inventions are concerned, there is a trend that publicly funded universities oppose an upfront buyout and assignment of foreground IP and instead merely offer an option to acquire rights in such inventions at fair market value. There are similar trends with respect to access to background IP. The reason for this is that these institutions are concerned that fully paid-up upfront assignments (or licenses to background IP) will be considered illicit state aid. Sponsors are well-advised to have a solid understanding of the anticipated value created by the research partner and fund their projects appropriately.Moreover, if the SRA is part of a wider EU or German government grant, the grant conditions may add more limitations on the Sponsor’s ability to dispose of the research results. Examples are mandatory use and exploitation requirements within the EU or Germany and approval requirements for exploitation of research results outside the EU.4. UNFETTERED PUBLICATION RIGHTS MAY AFFECT THE PATENTABLITY OF THE RESEARCH INVENTIONS AND LOSS OF TRADE SECRETSUniversity partners commonly seek the right to publish or publicly present the results or study data from the research under an SRA to maximize public access to the data. Without a mechanism in place to control the scope and forum of such disclosure, a Sponsor may risk losing the confidentiality and trade secret status of its proprietary information. Furthermore, the publication may be deemed a prior art disclosure, which may severely affect the patentability of the research inventions. A Sponsor often requests that a procedure be in place that requires the university to provide the Sponsor with the content of the publication well in advance, a right to review such content over a specified period of time, and the right to request, and often require, the removal of any of the Sponsor’s confidential information or trade secrets contained within the proposed publication. Sponsors may also seek to impose an “embargo period,” which is a specified period of time during which the university cannot publish the research results. The embargo period would be a sufficient period to allow the Sponsor to evaluate and file patent applications for the resulting inventions.Sponsors commissioning research in the EU should also be aware that in certain EU countries (e.g., Germany), if not contracted away, university scientists may have statutory rights to either publish their research results or to elect not to disclose their research results at all.5. CONSIDER LIMITING SPONSOR’S INDEMNITY OBLIGATIONSOverlooking indemnification provisions, often considered boilerplate, can be a serious mistake for a Sponsor. Failing to pay attention to an indemnity provision in terms of application and scope may result in Sponsor’s indemnity obligations extending to indemnification of all costs and expenses incurred by the university resulting from third-party claims and direct claims. In that case, the Sponsor may have to cover attorney’s fees and litigation expenses for its research partner in direct lawsuits between the research partner and the Sponsor. Additionally, Sponsors shouldn’t overlook the scope of the indemnification (i.e., from the Sponsor’s use or sale of the embodiments of the project research only) and include carve‑outs that exclude damages caused by the university’s gross negligence, intentional misconduct, or the illegal actions of the university’s principal investigator. It is also common to include the Sponsor’s right to control the defense and settlement of the indemnified claims.6. CONSIDER IMPACT THAT A CHANGE OF CONTROL HAS ON THE SRASponsors are often emerging growth companies, venture-backed companies, or companies who are otherwise anticipating some sort of exit in the future. These companies may likely go through different rounds of funding, asset sales, and public offerings during their life cycles. It is important that these significant events not be delayed, impacted, or conditioned by the requirement to obtain consent from a research partner pursuant to an SRA. Sponsors should be mindful to draft assignment clauses in order to permit the Sponsor to assign the SRA freely in important events such as an equity sale, asset sale, merger, or an assignment by operation of law.7. PAY ATTENTION TO THE EFFECTS OF TERMINATIONWhile it is important to pay attention to the scenarios pursuant to which an SRA may be terminated, termination provisions also commonly address the consequences following the termination. Ideally, the SRA should require the automatic reversion of any background IP licenses granted to the research partners. If the research partner needs to use the Sponsor’s background IP for wind-down activities following the termination, the parties should clarify the scope and limited term of the license for those activities. Additionally, consider what obligations will survive the termination of the SRA. For example, as a market standard, Sponsors and research partners often agree to a continued term, of a specified period of time, for the confidentiality obligations to the exchanged confidential information (other than trade secrets, the confidentiality of which commonly continues as long as the information remains a trade secret or as long as permissible under applicable law). Additionally, restrictions on publication of the study data often survive the termination of the SRA.8. CONSIDER NONDISCLOSURE AGREEMENTS BETWEEN THE RESEARCH PARTNER AND ITS THIRD-PARTY ADVISORS AND CONTRACTORSResearch partners often require the ability to disclose the Sponsor’s proprietary information to its third‑party advisors or contractors, often in order for the research partner to support the project pursuant to the statement of work or other scope document that is part of the SRA. Sponsors should take care to expand the scope of information subject to the confidentiality obligations of the SRA to include all of the information disclosed by the Sponsor to the research partner, whether or not the information is marked “confidential,” “proprietary,” or with some other similar marking. Additionally, Sponsors can limit the disclosure by the research partner to any third party to a “need-to-know” basis and only in order for the research partner to fulfill its obligations and requirements pursuant to the SRA. Additionally, SRAs often include a requirement that there be a confidentiality agreement between the research partner and each recipient of the Sponsor’s confidential information that is at least as protective of the Sponsor’s confidential information as the terms of the SRA. Note that absent such an agreement, a third-party consultant or advisor may freely disclose the Sponsor’s confidential information, trade secrets, and patentable subject matters.9. RIGHT TO CONTROL PATENT PROSECUTION AND ENFORCEMENTIt is important to ensure that the SRA provides clarity with respect to whether the Sponsor or the research partner will control patent prosecution and enforcement actions and how the costs and awards resulting from enforcement actions will be allocated. When allocating the rights to control patent prosecution and enforcement, note that it is common that the owner of the applicable intellectual property have the first option to take control over the prosecution process and any associated enforcement. Furthermore, if the parties agree on joint ownership of foreground IP, consider including in the SRA obligations of both parties to cooperate and join in an infringement lawsuit.10. ESTABLISH PROPER IP ASSIGNMENT AGREEMENTS BETWEEN THE RESEARCH PARTNER AND THE IP CONTRIBUTORSA university often involves its faculty members, staff, or contractors in conducting the research under an SRA. If there are no IP assignment agreements between the university and the IP contributors, the contributors may claim rights or ownership interests in the Sponsor’s intellectual property. Consequently, SRAs often contain representations from the research partner that it has properly entered into assignment agreements with individuals and entities involved in the research, which enable the transfer of rights or the license of IP from the research partner to the Sponsor. In some cases, the Sponsor may ask the university to provide forms for IP assignment agreements entered into between the university and its IP contributors as part of the diligence process.In the EU, and particularly in Germany, it is also common practice for Sponsors to enter into an additional agreement with faculty members of the university research partner that are crucial for the research project. This is due to certain research privileges that prohibited the university to assign research scientists to a specific project and to seek waiver of the right to conceal research results (see section 4). Stay up-to-date with the latest <a href="https://www.mofo.com/capabilities/life-sciences-transactions-licensing.html" target="_blank">Life Sciences Transactions + Licensing</a> developments by subscribing to MoFo’s <a href="https://lifesciences.mofo.com/" target="_blank">Life Sciences</a> blog.