In this model, industry does not want to incur the sole-sponsor or co-sponsor role, or wishes to limit its responsibility as a (co-)sponsor. At the same time, it may intervene or extend control on a number of aspects beyond the limited involvement in IIS, for instance, initiation of the project, input to study design, arranging supply of products and funding, stronger rights on ownership and use of study results, more control in relationship with authorities and third party stakeholders, and extensive collaboration on elaborating the study report and publications.
Compared to the typical IIS approach, collaborative work allows industry to ensure better alignment of the project with its clinical development strategy. Certain key points should be borne in mind for structuring these relationships, including:
- regulatory role allocation must be clear from the outset in all relevant documentation;
- tasks described under the contract and related documentation must be consistent;
- if the collaborating institution is still intended to be the sole sponsor, it needs to retain decision-making power. This requires a subtle balance in governance to secure oversight and protection and desired control for the industry. In case of co-sponsoring, the allocation of responsibilities is even more important.
- IP ownership and use must take into account industry contribution, with further rights granted vs. IIS;
- the hybrid nature of these studies will require amending contract provisions deriving from both sponsored and ISS studies;
- key documentation must be legally reviewed to spot inconsistencies and risk of reclassification as sponsor or co-sponsor (e.g., contract must be explicit on subcontracting of regulatory tasks); and
- civil law liability and indemnification to be specified in close alignment with roles and actual activities.
Please contact the authors or the Hogan Lovells attorneys with whom you regularly work to discuss your specific collaboration needs.
This is an article in our 2023 series, “Life Sciences Transactional Insights”, which aims to provide key practical takeaways for our transactional colleagues by anticipating the needs of their regulatory, intellectual property, and business stakeholders. Our dedicated team of life sciences and health care licensing and commercial transactions lawyers understand the challenges and opportunities that strategic alliances and other partnering relationships present. We draw on the depth of our life sciences practice and work seamlessly with our regulatory experts to provide unparalleled transactional support. Ensure you are subscribed to Hogan Lovells Engage to receive our insights.
Authored by Mikael Salmela and Joerg Schickert.