Overview
Dr. Monika Richter advises national and international biotechnology/pharmaceuticals companies on various commercial legal matters related to the development, manufacturing and commercialization of medicinal products, with a particular focus on strategic alliances, research and development collaborations, license agreements, commercial manufacturing and supply agreements and distribution agreements. Her work likewise includes financing and corporate transactions as well as mergers and acquisitions.
Given her Polish background, Monika Richter is active in the Eastern European market, regularly speaking at industry conferences in Poland and advising Polish clients on several cross-border collaborations in the life sciences sector.
Results
Monika advised:
- Ryvu Therapeutics (formerly named Selvita), one of Poland’s largest biotechnology companies, on an exclusive license agreement with Exelixis and on various other international licensing and collaboration agreements, including with Orion Pharma, H3, Felicitex, Merck, and Menarini, and on a funding agreement with the Leukemia and Lymphoma Society
- Moffitt Cancer Center, a world leader in advancing cellular immunotherapies for the treatment of cancer, in its strategic alliance with Turnstone Biologics
- Paion on license agreements for the development and commercialization of Remimazolam in various territories, e.g., with Cristalia Produtos Quimicos Farmaceuticos (Brazil), Mundipharma (Japan), and TTY (Taiwan), as well as on various distribution agreements and commercial manufacturing and supply agreements regarding Remimazolam and other products
- lifespin on research cooperation with Biobank Graz and the Clinical Department of Oncology of the Medical University of Graz
- REGENXBIO on co-development and licensing partnership with AbbVie for development of RGX-314, a potential one-time gene therapy for retinal diseases
- STADA on the exclusive licensing transaction with Calliditas for commercialization of a novel specialty drug for the treatment of chronic autoimmune kidney disease
- Merck on an out-licensing transaction with Diaccurate, on a co-development and licensing partnership with Neuroloop (B. Braun start-up) for the development of a neurostimulator device for treatment of chronic inflammatory diseases and on various other collaboration agreements
- Biogen on various in-licensing collaborations, including with Reborna (Takeda spin-out), Cevec, iSD
- Treeway on the out-licensing transaction with Ferrer for the development of a compound for the treatment of ALS and other neurodegenerative diseases
- Adamed on the out-licensing transaction with Acadia on an early-stage compound
- OncoArendi on the out-licensing transaction with Galapagos for the development of clinical stage candidate for the treatment of fibrotic diseases
Recognitions
- Handelsblatt/Best Lawyers™, Germany: Biotechnology Law and Life Sciences Practice and Mergers and Acquisitions Law, 2021-2025
- Thomson Reuters, “Stand-out Lawyer” – independently rated lawyers, 2023-2024
- The Legal 500 EMEA, “Rising Star” in Germany: Healthcare and Life Sciences, 2024
- The Legal 500 EMEA, 2022-2023
- Leaders League’ 2019 Guide: Innovation, Technology & Patents, “Excellent”: Health, Pharma & Biotechnology
