BioTime Human Embryonic Stem Cell LInes
BioTime has agreed to provide access to five research grade versions of clinical-grade human embryonic stem cell lines to California researchers and future access to the GMP versions of these lines in one year. The letter agreement between CIRM and BioTime sets forth pre-negotiated terms and a template Material Transfer Agreement in order to assist in accelerating access. Key terms of the agreement provide:
- Access to CIRM grantees and California researchers of research grade cell lines at $2,500 per ampoule; no other charges for research use.
- Access to GMP grade lines along with a letter of cross-reference to a Biologics Master File (BMF) containing the manufacturing and controls information and additional documentation needed to establish GMP compliance and complete DNA sequence information on the lines will be available at the supplier’s cost.
- For Commercial Use: a royalty cap of 2% of net sales reducible to 1.5% in the event additional royalties are owed in resulting product commercialization. The parties may seek to negotiate more favorable terms. Cost per ampoule to be negotiated, in good faith, and to approximate costs of BioTime and its subsidiary.
- CIRM has not obtained agreements with or commitments from other third parties. Permissions, licenses, from third parties, for instance by WARF, may be required.
To acquire the lines:
Interested parties should contact Walter Funk at BioTime: