Search for:

With the healthcare and life sciences sector at the heart of the pandemic, we are seeing some new issues arising in the already complex world of life sciences collaborations, for both coronavirus-related and other products and therapies.

The Life Sciences Collaborations: Key Considerations in the COVID-19 Era document is a high-level guide that outlines a list of issues that to consider in executing these types of agreements in the COVID-19 era. This includes areas such as: governance, development and regulatory activities, manufacture and supply, commercialization, diligence, licenses and exclusivity, financial provisions, IP, representations, warranties and indemnifications, dispute resolution and risk management, and antitrust.

Our team of over 800 attorneys dedicated to the healthcare and life sciences industry across 46 countries in the transactional, regulatory, antitrust, intellectual property and data compliance practice groups is experienced in addressing the issues impacting the research, development, manufacturing and commercialization of your products.

Please click on the button below to request for access or contact your Baker McKenzie lawyer.

 

Author

Khelin Aiken practices in the area of US Food and Drug Administration regulatory and compliance law. She leverages her deep understanding of the US Food Drug & Cosmetic Act, US Public Health Service Act and their implementing regulations along with her prior experience at the US Food and Drug Administration (FDA) to help clients develop and achieve their strategic business objectives. Khelin previously served as regulatory counsel at the FDA in the Center for Drug Evaluation and Research, in both the Office of Regulatory Policy and in the Office of New Drugs with the Therapeutic Biologics and Biosimilars Staff.

Author

Dr. Christian Burholt is a partner in the Firm's Berlin office. He has more than 14 years of experience representing German and international clients in antitrust, dominance, and merger control law matters. He has been recommended for antitrust and merger control law in regulated industries by Juve since 2010. Prior to joining Baker McKenzie in 2015, Christian was for seven years a member of the antitrust team of a major international law firm, and led for five years the antitrust practice group of Germany’s leading pharmaceutical and healthcare law boutique. Christian is admitted to the Berlin bar and a member of the German Association of Antitrust Lawyers and the Network Compliance. He regularly lectures and publishes on antitrust and merger control topics.

Author

Vanina Caniza is a partner in Baker McKenzie’s Buenos Aires office. She advises clients in a variety of corporate and commercial law matters, with extensive experience in corporate compliance, commercial agreements and mergers & acquisitions. She represents and advises Argentine and foreign companies. She completed postgraduate courses on Biotechnology at Universidad Torcuato di Tella (Buenos Aires) and on Health Law at Universidad de Buenos Aires. She sits on the Steering Committee of the Firm’s Latin America Corporate Compliance Group and on the Steering Committee of the Firm’s Latin America Pharmaceuticals & Healthcare Industry Group. She is currently a professor in the CEC Compliance & Ethics Certification (AAEC-UCEMA).

Author

Mark Goodman is a partner in the Firm's San Francisco office who serves as co-Chair of the firm’s North America Commercial Litigation group and is part of the North America Trial Team. Mark has led complex multidistrict litigation, handled class actions and tried cases in state and federal courts across the US for both domestic and international clients. Mark regularly presents on product liability, risk mitigation and cross-border disputes. Listed in Who's Who in American Law and a Fellow of the American Bar Association, Mark has been regularly recognized as a Northern California Super Lawyer, a member of the Legal 500 and as a member of the International Who's Who of Professionals.

Author

Author

Jane E. Hobson is a partner in Baker Mckenzie's London office. She works in the Firm's London Corporate group, is a member of the Global M&A Practice Group, and focuses on cross-border mergers and acquisitions, licensing transactions and joint ventures in the pharmaceutical and healthcare sector.

Author

Author

Dr. Isabella Liu is the head of the Firm's Asia Pacific Healthcare Industry Group. She advises clients on matters relating to the creation, exploitation and protection of IP rights. She is also responsible for the local IP Group’s China and Hong Kong patent prosecution matters. Dr. Liu is ranked as a leading lawyer in her field by top legal directories such as Chambers Asia Pacific for the Life Sciences category and IAM Patent. She has been complimented by clients that she possesses “a superb ability to understand the most complex technologies” and was noted for "advis[ing] in a way that is very commercial and strategic."

Author

Oren Livne is a partner in the Corporate & Securities Practice Group and the Life Sciences Industry Group. Prior to beginning his law career, Oren co-founded a university technology transfer office and managed its licensing operations, which, together with his M.B.A, from New York University's Leonard N. Stern School of Business, provide a unique business perspective that he leverages for the benefit of the firm's clients.

Author

Creighton Macy has extensive experience representing clients in a wide variety of antitrust matters, including mergers and acquisitions, investigations by the United States Department of Justice and the Federal Trade Commission, private litigation, and counselling on issues such as antitrust compliance. Before joining the Firm, Creighton served as chief of staff and senior counsel in the Department of Justice Antitrust Division, working as a senior advisor to the acting assistant attorney general on civil and criminal antitrust enforcement and policy matters, as well as budget and personnel issues. During Creighton's time at the DOJ, the Antitrust Division undertook an unprecedented volume of high-profile civil and criminal matters.

Author

Toby Patten is a partner in Baker McKenzie's Technology and Healthcare teams in Melbourne. He joined the Firm in March 2005.

Author

Veleka Peeples-Dyer is Chair, North America FDA Practice Group for Baker McKenzie. Veleka brings more than 20 years of strategic and practical business and legal counsel to a wide span of biopharmaceutical companies, advising on FDA regulatory and compliance matters, including over 15 years of senior in-house counsel experience in leading biopharmaceutical companies.

Author

Denis Segota is a partner in the Corporate & Securities Practice Group and a member of the Life Sciences Industry Group at Baker McKenzie in New York. Denis has over 20 years of experience in counselling clients in the life science industry. His clients range from early stage start-ups, life science venture and other private equity funds to multinational pharmaceutical companies. Denis assists companies with complex joint ventures, strategic alliances, licensing, and other partnering arrangements promoting the research, development, and commercialization of new products.

Author

Hiroshi Sheraton's practice covers all aspects of intellectual property law with a particular emphasis on contentious patent and trade mark matters and life sciences. Much of his work is cross-border in nature. He regularly co-ordinates pan-European and global IP litigation and advises clients on international IP strategies for patent litigation and brand protection. He represents clients in the UKIPO, EPO, OHIM, the English Courts and the CJEU. He has experience of IP matters across Europe and has litigated IP cases in Germany, France, Spain, Italy, the Netherlands, Belgium, Austria, Ireland, Northern Ireland and Luxembourg, the USA and Asia Pacific. Although he has a first degree in biochemistry and molecular biology, he covers all areas of technology from pharmaceuticals/biotech products and agrochemicals to electronics and software.

Author

Iona Silverman is an Associate in Baker McKenzie's London office.

Author

Randall Sunberg is a partner in the Corporate & Securities Practice Group and the Life Sciences Industry Group. He also serves as the co-head of the North America Life Sciences practice. Randy structures and negotiates complex collaborations, mergers and acquisitions, divestitures, joint ventures, and corporate partnering and licensing transactions, as well as equity investments and royalty monetization transactions for clients ranging from biotech startups to multinational pharmaceutical companies.

Author

Barry is a partner in Baker McKenzie's Los Angeles office. For over 25 years, he has litigated and tried complex commercial and product liability cases in state and federal courts across the country. These include numerous "bet-the-company" cases and, more recently, contingency / partial contingency fee cases, where Baker takes a stake in the litigation. Barry has represented a variety of clients over the years from high net-worth entertainers to Fortune 100 pharmaceutical and consumer product companies. He is a member of the Firm's National Trial Team and the Litigation Chair for Baker's California Offices. Barry loves being in the courtroom and is entirely at ease in front of a jury. He never assumes a case will settle, which means his cases undergo an early case assessment (ECA) as well as development of a strategic plan, budget, and themes of the case. At every stage, Barry assesses how new and developing facts, witnesses and documents fit the strategic plan, budget and themes. He also works tirelessly to learn the strengths and weaknesses of his case, to stay ahead of his opponents, and to keep his clients well-informed and well-positioned to settle or try the case, depending on their goals and objectives.

Author

Elisabeth White is a partner in Baker McKenzie's Sydney office. Elisabeth has over 15 years' experience as an intellectual property and regulatory advisor, focusing upon IP protection and enforcement with a particular emphasis on regulated industries and related disputes. Elisabeth is described in Asia Pacific Legal 500 as providing “decisive expert opinion and a pragmatic approach”. She has been featured in Best Lawyers - Intellectual Property listed annually since 2013.

Author

Dr. Constanze Ulmer-Eilfort is a member of the Firm's Global Executive Committee and chair of the EMEA region. Previously, from 2012-2017, she was the managing partner of the German and Austrian offices. Constanze has more than 20 years experience in advising high technology, pharmaceutical and media companies on the protection and commercialization of intellectual property rights. She advises on a broad range of agreements such as collaboration and license agreements, R&D agreements and agreements with academic institutions. Furthermore, she is also seasoned in the field of copyright. Constanze is ranked by JUVE, Legal 500 and Chambers as a leading lawyer in life sciences transactions and in copyright and has been awarded with the "Overall Outstanding Female Practitioner Award" at the 2016 Euromoney European Women in Business Law Awards and the PMN Awards as Managing Partner of the year 2015.