Insights and Analysis

How to Negotiate Cell & Gene Therapy Contracts with German Treatment Centers

Trends in Cell, Tissue, and Gene Therapies

04 November 2025

For autologous cell and gene therapies (CGTs), the collection of patients‘ cells is the first step in the manufacture of the medicinal product. In Germany, this step is usually conducted by specialized treatment centers that have their own cell collection unit and thus handle both the cell collection as well as the later storage, handling, and administration of the finished drug product. Due to Good Manufacturing Practice (GMP) requirements and contractual risks arising from the cell collection, and from the handling of the collected cells and the finished drug product, a pharmaceutical company must implement appropriate agreements with treatment centers.

Usually, German treatment centers with the ability to provide cell collection services and to handle and administer complex CGTs are university hospitals, and therefore public entities. This fact heavily impacts the contract negotiations, which differ quite significantly from negotiations with private companies. In particular, treatment centers are very reluctant to take on financial risks, arguing they have limited financial resources, and strict budgets that cannot permit unplanned costs.

Hence, there is a heightened focus in the following elements of contracts negotiated with treatment centers in Germany:

Cancellation of orders if product cannot be administered as planned;
Loss of product after delivery;
Payment of apheresis services fees by the pharmaceutical company (as required by the German public health insurance) when there is no supply of a finished product;
Liability and indemnification, including the demarcation of product liability and liability for medical malpractice; and
Intellectual property as German public institutions usually argue that they can not transfer or license any IP (including IP that relies on or relates to the company’s medicinal product) generated under a contract to a private company without additional charge.

As a result of the treatment centers’ often rigid approach to contract terms and negotiations, but also due to limited resources on their end, the contract review and negotiation processes tend to be lengthy. This is even more the case for some treatment centers that do not operate their own cell collection unit but collaborate with third party cell collection providers which may be involved in the contract negotiation process with their own requirements and interests.

Therefore, companies negotiating agreements with German treatment centers should discuss the abovementioned contract elements at an early stage (ideally starting 12 months before the contemplated product launch date) and carry out an internal risk assessment to identify possible solutions. This may help expedite the negotiation process.

Negotiations can also be expedited – at least to some extent – by using contract templates that address common concerns of treatment centers, and by planning fallback positions for key terms in advance of the process.

Authored by Dr. Benjamin Goehl and Dr. Tina Welter-Birk

This article is the fifth in our new series, “Trends in Cell, Tissue, and Gene Therapies,” which aims to help you stay informed about the broad array of legal and regulatory issues affecting companies operating in the regenerative medicine space. From clinical studies, to obtaining patents, to scaling up manufacturing, our global team will discuss novel issues arising in all parts of the world, including unique deal-making, litigation, and inspections concerns for CTGT companies. Ensure you are subscribed to Our Thinking to receive these new insights weekly!