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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Sponsored Research Agreements (SRA) are used by companies to contract a research organization, such as a university, to conduct research and development activit

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Top 10 Considerations When Drafting and Negotiating SRAs, with U.S. and EU Perspectives

Top 10 Considerations When Drafting and Negotiating SRAs, with U.S. and EU Perspectives | MoFo Life Sciences

Matt Karlyn

Robert Grohmann

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.

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