LSHC Horizons Brochure 2024 - Flipbook - Page 25
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | Cell, Tissue, and Gene Therapies
Negotiating cell, tissue, and gene therapy agreements with HCOs
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 long
before obtaining marketing authorization for a
CTGT product.
From our experience, in particular, the
following key terms are often controversial:
• ownership of patient cells collected
by the institution (which, depending on
the local laws applicable may also need
to be aligned with a respective consent by
the patient waiving ownership rights in
their cells);
• liability, indemnification, and
insurance, specifically with regard to the
demarcation of product liability (to be borne
by the pharmaceutical company anyway)
and medical malpractice. This is particularly
challenging for CTGTs where the hospital
is closely involved in the manufacturing
of the product and its, often very specific,
preparation and handling.
Public hospitals tend to not be very flexible
in terms of accepting contractual clauses to
their disadvantage; in addition, they often
have rather long review cycles. Therefore,
it is important to develop very clear and
balanced template agreements in order to not
delay negotiations. In European Union (EU)
countries an EU-wide template agreement
can be the starting point, but it needs to be
localized for key jurisdictions in order to ensure
a smooth negotiation process with local ATCs.
Also, a negotiation handbook providing for
fallback positions in respect to the above and
further topics can facilitate swifter negotiating.
• loss of cells and/or product;
• intellectual property, in particular with
respect to ownership of product-related
inventions made by institution’s employees
(although rather unlikely); and
Dr. Jörg Schickert
Partner
Munich
Dr. Benjamin Goehl
Senior Associate
Munich
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