Life Sciences Horizons Brochure 2025 - Flipbook - Page 42
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2025 Horizons Life Sciences and Health Care
Planning contract negotiations with treatment centers in Germany
For autologous cell and gene therapies, 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 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 when there is no supply
of a finished product; and,
Liability and indemnification, including the demarcation
of product liability and liability for medical malpractice.
As a result, companies negotiating with German treatment
centers should discuss these 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, which is critical as review processes at
treatment centers are often lengthy due to limited resources.
Negotiations can also be expedited – at least to some extent –
by using contract templates that address common concerns,
and by planning fallback positions for key terms in advance
of the process.
Dr. Tina Welter-Birk
Counsel
Munich
Dr. Benjamin Goehl
Senior Associate
Munich
