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Rare Disease Innovation & Partnering Summit

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Morrison & Foerster is proud to sponsor Informa's 2022 Rare Disease Innovation & Partnering Summit on May 17-19. This hybrid event will take place in Boston.



Morrison & Foerster is proud to sponsor Informa's 2022 Rare Disease Innovation & Partnering Summit on May 17-19. This hybrid event will take place in Boston.Join Morrison & Foerster attorneys Erik Olson and Brigid Bondoc and Advanced Cell & Gene Therapy Principal Scott Burger on May 18th from 2:30-3:15pm EST as they participate in the panel, Uncover Risk Disclosures for Gene Therapies.During this session, speakers will:<ul><li>Outline the risks of gene therapy and how they have changed over the years as the science has improved</li><li>Discuss how the SEC thinks about risk disclosure, particularly in a situation where the risk isn’t just money</li><li>Discuss the FDA’s role in controlling risk and balancing against benefits and cooperation with SEC</li><li>Explore shareholder litigation</li><li>Participate in case studies</li></ul>The conference will focus on solution-focused strategies surrounding patient access, reimbursement, commercialization, launch, partnering and more. Join experts across the rare disease community, in-person or virtually, to unite in areas of unmet medical need and create life-transforming therapies and breakthroughs.<hr>

Rare Disease Innovation & Partnering Summit

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Erik Olson’s practice focuses on the litigation of securities, corporate governance, and intellectual property disputes, with particular emphasis on clients in the biotechnology, medical device, telecommunications, and high-technology industries.Erik regularly represents executives, directors, and companies in suits arising from actual or potential mergers, acquisitions, and other strategic transactions. Between 2008 and 2016, Erik has directed teams that defeated preliminary injunction motions, obtained dismissals, or favorably resolved more than twenty cases involving challenges by shareholders to public merger transactions. He is one of the primary authors of the Association of Corporate Counsel’s “White Paper” on managing class action merger litigation. In fall 2016, Erik served as SoftBank Group Corporations’ lead counsel in a trial in the Delaware Court of Chancery that addressed claims by stockholders of Clearwire Corporation that Sprint breached its fiduciary duties in connection with a 2013 acquisition of Clearwire. The trial also concerned stockholders’ claims to an appraisal in connection with the same merger.In 2012 and 2013, Erik served as SoftBank’s primary litigation counsel in connection with state and federal claims that sought to enjoin SoftBank’s acquisition of a controlling interest in Sprint Nextel Corporation and that sought to enjoin the related merger between Sprint Nextel Corporation and Clearwire Corporation. In the Sprint litigation, the lead plaintiffs ultimately withdrew their requests for a preliminary injunction prior to the consummation of the merger and later voluntarily dismissed their claims. Erik served as one of Cogent Inc.’s lead counsel in litigation that sought to enjoin Cogent’s merger with the 3M Company. The Delaware Court of Chancery denied plaintiffs’ motion for a preliminary injunction.In other securities-related matters, Erik has repeatedly obtained dismissals of federal class action lawsuits under the Private Securities Litigation Reform Act and successfully defended those dismissals before the Fourth, Ninth and Tenth Circuits.In 2010 and 2011, Erik obtained a dismissal with prejudice of derivative and class action claims filed against Crocs, Inc., the directors and officers of Crocs, Inc., and Global Cash Access, Inc. In each case, Erik’s clients were successful following a first motion to dismiss. He has also successfully persuaded the SEC to conclude, without penalties, investigations into alleged federal securities law violations for dozens of companies and individuals across a broad range of industries.Erik regularly works on behalf of audit committees and special committees of boards of directors conducting confidential investigations of whistleblower allegations, alleged violations of federal law, and alleged accounting misconduct, such as the allegedly improper recognition of revenue, write-offs concerning inventory and other assets, or the alleged violations of companies’ internal controls.In intellectual property-related matters, Erik regularly assists high-technology, telecommunications and life sciences companies in the prosecution or defense of intellectual property lawsuits with competitors regarding consumer electronics, smartphones, telecommunications equipment, biotechnology products, drugs, or medical devices. Erik served as patentee’s counsel in connection with three high profile patent disputes between major smartphone manufacturers, including in a trial in which the jury awarded the patentee over $1 billion. In 2016, Erik helped Sandoz secure a victory in its patent and intellectual property dispute with Amgen, leading to the introduction of the first “biosimilar” pharmaceutical product under the Affordable Care Act’s Biologics Price Competition and Innovation Act (BPCIA). The case addressed groundbreaking issues regarding the BPCIA’s procedures related to when and how brand name biotechnology companies can assert patents in an effort to stop the introduction of new competition. Erik previously served as a chief architect of the University of California’s patent infringement victory over The Monsanto Company regarding claims to recombinant bovine growth hormone. The resulting settlement, valued at more than $200 million, ranked at the time as one of the top ten settlements in any biotechnology patent case in the United States. Erik advises both patent holders and defendants in connection with intellectual property claims across the country.Erik has served as counsel in numerous state and federal courts, in private arbitrations, and in proceedings before the SEC. He has handled appeals in the California Court of Appeals and the United States Circuit Courts of Appeals for the Third, Fourth, Ninth, Tenth, Eleventh, D.C., and Federal Circuits.From 2007-2008, Erik served as chair of the Litigation Section of the State Bar of California. From 2005-2007, he also served as chair of the Litigation Section’s Rules & Legislation Committee, which reviewed and comments on legislative and rule changes that affect civil litigation in California. Erik currently serves as a member of Morrison & Foerster’s board of directors and serves as Treasurer for the Law Foundation of Silicon Valley, the largest pro bono service provider in Santa Clara County (San Jose, California).Erik graduated from Stanford Law School. While at Stanford, he was elected to the Order of the Coif and was the recipient of the Morie Award for outstanding legal writing.<h4>Representative Experience</h4><ul dir="ltr"><li>Smartphone Litigation Co-led a team that successfully tried a series of high-profile smartphone cases, including a jury verdict of over $1 billion.</li><li>Amgen Inc., et al. v. Sandoz Inc., et al. (U.S. District Court for N.D. Cal., Federal Circuit). Secured a victory on behalf of Sandoz Inc. in the first case to interpret the Affordable Care Act’s Biologics Price Competition and Innovation Act (BPCIA). The federal district court ruled in Sandoz’s favor on all issues before the court, adopting Sandoz’s interpretation of the BPCIA in all respects. The court also denied Amgen’s motions urging a contrary interpretation and seeking a preliminary injunction. The Federal Circuit later affirmed the key elements of Sandoz victory. Erik current represents Sandoz in disputes regarding patents directed toward the purification of proteins expressed using recombinant DNA technology.</li><li>In re Sprint Merger Litigation (Kansas District Court; U.S. District Court for the District of Kansas). Represented SoftBank Corporation in litigation that sought to prevent its acquisition of a controlling interest in Sprint Nextel Corporation. Plaintiffs ultimately withdrew their request for a preliminary injunction after oral argument and then voluntarily dismissed their claims after the transaction closed. (2012-2013).</li><li>In re Clearwire Merger and Appraisal Litigation (ACP v. Sprint Corp.) (Delaware Court of Chancery). Representing SoftBank Corporation in breach of fiduciary duty and appraisal litigation associated with Sprint’s cash merger with Clearwire Corporation. Served as lead counsel at a trial of the fiduciary duty and appraisal claims in the fall of 2016. The case is currently one of the largest appraisal actions ongoing in the Court of Chancery.</li><li>In re Crocs, Inc. Securities Litigation; Wheeler v. Snyder, et al. (D. Colo.). Represented Crocs, Inc. and certain of its current and former officers and directors in shareholder derivative lawsuits filed in Colorado. In February 2009, won dismissal of all derivative claims, with prejudice, on first motion to dismiss. No appeal was filed.</li><li>In re Crocs Inc. Securities Litigation (D. Colo.). Represented Crocs, Inc. and its current and former officers and directors in shareholder class actions (claiming violations of the Exchange Act). Won dismissal of all claims with prejudice pursuant to the Securities Litigation Reform Act of 1995 on a first motion to dismiss.</li><li>In re Cogent Merger Litigation (Del. Court of Chancery & Los Angeles County Superior Court). Represented Cogent Inc. and its directors in a lawsuit challenging its merger with the 3M Company. Successfully defeated a motion seeking a preliminary injunction to enjoin the transaction based on alleged breach of fiduciary duties.</li><li>In re Ameristar Merger Litigation (Nevada State Court). On behalf of Pinnacle Entertainment, the buyer of Ameristar Casinos, defeated motions seeking a preliminary injunction against the closing of the merger and obtained a dismissal of plaintiffs claim.</li><li>In re Global Cash Access Securities Litigation (D. Nev.). Represented Global Cash Access and its executives in securities litigation brought against a payment processor who specialized in the gaming industry. Successfully dismissed certain initial claims and then obtained a favorable settlement, which was fully covered by insurance.</li><li>Hattan v. RH, Inc. (Marin County Superior Court). Reached a favorable settlement on behalf of RH in connection with shareholder litigation stemming from a going-private transaction.</li><li>Ned v. Titan Pharm. Inc., et al. (N.D. Cal.). On behalf of Titan Pharmaceuticals, obtained voluntary dismissal of pending class action securities claims against Titan without need to file a motion to dismiss.</li><li>In re Telik Inc. Securities Litigation (S.D.N.Y.). On behalf of Telik Inc., successfully settled a class action litigation challenging the disclosure of Phase III clinical trial results based on payments by insurers without the need for costly or burdensome discovery.</li><li>Baht v. Global Defense Technology & Systems, Inc. (Del. Court of Chancery). Representing Global Defense Technology & Systems Inc. and its directors in litigation challenging its proposed merger with a private equity buyer.</li><li>Elan v. Abraxis (U.S. District Court for the District of Delaware). Represented Abraxis in its high profile patent dispute and trial with Elan regarding technology used in the delivery of chemotherapy agents.</li><li>SEC Investigations. Successfully persuaded the SEC to conclude, without penalties, investigations into alleged federal securities law violations at a software company, a home goods retailer, and a medical device manufacturer. (2005-2011)</li><li dir="ltr">Stock-Options Investigations. Represented multiple U.S. public companies with far-reaching internal investigations regarding the company’s employee stock-option program. (2006-2007)</li></ul><h4>Leadership Roles</h4><ul dir="ltr"><li dir="ltr">Current member of Morrison Foerster’s board of directors</li><li>Treasurer and chair of the Finance Committee for the Law Foundation of Silicon Valley, the largest pro bono service provider in Santa Clara County (San Jose, California)</li><li>Serves on the committee that evaluates civil rule changes in the Northern District of California</li><li>Chair of the Litigation Section of the State Bar of California (2007 – 2008)</li><li>Chair of the Litigation Section’s Rules & Legislation Committee (2005 – 2007)</li></ul>

Erik J. Olson

Partner

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.As a member of our FDA + Healthcare Regulatory and Compliance Group, Brigid practices across the spectrum of FDA-regulated products, including medical devices, drugs, biologics, cell and gene therapies, food, cosmetics, dietary supplements, tobacco, laboratory-developed tests, in vitro diagnostics, radiation-emitting electronic products, combination products, and products that may not fit neatly into any of these categories. Accordingly, she counsels established and start-up companies in life sciences, healthcare, and consumer products on a wide range of FDA pre- and post-market regulatory issues. Brigid also frequently advises innovative product developers on threshold FDA jurisdictional questions and develops strategies for approval and marketing, while identifying and mitigating regulatory risks.In her day-to-day practice, Brigid advises on:<ul><li>product development and FDA’s pre-authorization requirements;</li><li>advertising and promotion of FDA-regulated products;</li><li>clinical trials regulation, including strategic advice for sponsors in receipt of a clinical hold;</li><li>responses to warning letters, Form 483s, import alerts, and FDA enforcement actions;</li><li>informal and formal dispute resolution for high-stakes issues;</li><li>compliance with FDA regulatory requirements such as current good manufacturing practice (GMP), quality system regulation (QSR), food safety preventive controls, adverse event reports, product recalls, radiological health issues, risk evaluation and mitigation strategies (REMS), pharmacy compounding and the new track-and-trace regulations for prescription drugs; and</li><li>technical legal questions involving the Food, Drug and Cosmetic Act (FDCA), the Public Health Service Act (PHSA), Federal Advisory Committee Act (FACA), Freedom of Information Act (FOIA), and the Administrative Procedure Act (APA).</li></ul>Brigid also has experience in the development, regulation, and procurement of medical countermeasures (MCMs) against chemical, biological, radiological, and nuclear (CBRN) threats and pandemic infectious diseases, including animal rule approvals and special incentives for the development of MCMs.Complementing her focus on FDA regulatory law, Brigid has a strong litigation background and has served as FDA counsel in product liability cases, civil litigation, international arbitration, and FDA enforcement proceedings. She particularly enjoys providing clients with advice that integrates technical, legal, and political considerations.Brigid maintains an active pro bono practice focused primarily on reproductive health and especially enjoys working with inventors who aim to improve health outcomes for mothers and infants in the peri- and post-natal period. She has represented several clients before the Social Security Administration in appealing denials of applications for disability benefits. She has also worked on several appeals in criminal cases in the District of Columbia.Brigid is a graduate of the University of Tulsa, where she earned her B.S. in biochemistry before attending law school at Stanford Law School. Prior to law school, Brigid worked as an Environmental Policy Analyst in the Office of the Secretary at the U.S. Department of Transportation. She has also worked as a benchtop scientist in a number of laboratories, including FDA’s National Center for Toxicological Research.<h4>Representative Experience</h4><ul><li>Counseled online marketplaces regarding FDA compliance and enforcement for a variety of products.</li><li>Advised development-stage companies on regulatory considerations and FDA engagement strategies related to development and launch of products based on disruptive technologies.</li><li>Advised consumer technology companies with respect to potential FDA regulation under the medical device provisions of the FDCA;</li><li>Served as FDA regulatory counsel to clients evaluating compliance issues under reporting provisions of Corporate Integrity Agreements and related negotiated resolutions of government investigations.</li><li>Helped a large, publicly traded drug company comply with the FDA’s new track-and-trace pedigree requirements for prescription drugs.</li><li>Led regulatory team on numerous initial public offerings (IPO), stock and asset purchase agreements, acquisitions, mergers, and other transactions for life science company.</li><li>Provided strategic advice, conducting regulatory assessments and negotiating key FDA-related terms in connection with due diligence for transactions and post-acquisition integration activities.</li><li>Developed policy positions related to FDA regulation of laboratory-developed tests (LDTs) for multiple clients in this space.</li><li>Represented manufacturers in matters involving regulatory letters, inquiries, advisory comment proceedings, competitor complaints and citizen petitions focused on their products and policy issues affecting their strategic priorities.</li><li>Advised on issues related to promotion of drugs and medical devices, including communication of pharmacoeconomic/healthcare economic information (HCEI), communications by medical science liaisons (MSLs).</li><li>Provided solutions-oriented advice to development-stage companies confronting FDA regulatory issues for the first time, including good clinical practices (GCP), investigator-initiated research (IIR), pre-approval communications and strategies for obtaining FDA approval.</li><li>Collaboratively advised client on FDA, ethical, and product liability issues associated with early termination of a clinical study involving an implanted medical device.</li></ul>

Brigid Bondoc

Life Sciences + Healthcare

Patent Litigation

FDA + Healthcare Regulatory and Compliance

Rare Disease Innovation & Partnering Summit - 576184431

Rare Disease Innovation & Partnering Summit

18 May 2022 5:30 PM - 6:15 PM EDT