Lexology July 31, 2024
This is an article in our “Life Sciences Transactional Insights” series, which aims to provide key practical takeaways for our transactional colleagues by anticipating the needs of their regulatory, intellectual property, and business stakeholders.
Legal challenges for innovative cell, tissue, and gene therapies (CTGTs) are mainly seen in the still evolving regulatory environment. However, it is also crucial for the manufacture and supply of CTGTs to have agreements in place with all apheresis and treatment centers (ATCs) in the respective launch markets. CTGT companies should be aware that the negotiating and execution of such agreements with (often public) hospitals and other health care organizations (HCOs) can be both challenging and time-consuming. That process should thus be thoroughly planned and initiated...
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