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What is the CIRM hPSC Repository?
The CIRM hPSC Repository is a bank of human pluripotent stem cell (hPSC) containing one line from each of approximately 3,000 donors, 80% of which come from patients having a variety of multigenic disorders and the balance being controls. The patients/donors were selected by leading California researchers to create informative iPSC lines. Patient samples were converted into iPSC lines by Cellular Dynamics International, Inc. (CDI), a FUJIFILM company, using its proprietary episomal reprogramming method that does not introduce exogenous DNA into the iPSC lines. The CIRM Repository is maintained and administered by the Coriell Institute for Medical Research (Coriell), which is also responsible for storing and distributing de-identified patient clinical information associated with the CIRM Repository samples.
What do I need to do in order to access a sample from the CIRM Repository?
Every requestor must execute a Material Transfer Agreement with Coriell, which can be downloaded from this website, and complete the online ordering process. Commercial entities and academics or non-profits engaged in commercial activities must take a patent license from CDI using the Standard License Agreement for the CIRM hPSC Repository, also found on this website. Commercial activity by an academic or non-profit entity is defined as fee-for-service or sponsored research or other arrangements in which another party has rights to the output of the work performed, even if the work is done by a non-profit.
What are the fees for access to the iPSC lines?
There are two separate fees associated with the CIRM Repository. There is a fee of $1500 per vial of hPSCs for a commercial entity and $750 per vial for an academic or non-profit entity. If an entity needs a patent license, a separate fee will be paid to CDI under the Standard License Agreement.
If I need a patent license, what do I need to do?
A potential requester who wishes to be licensed can print out the Standard License Agreement for the CIRM hPSC Repository, execute it by a duly authorized person, and deliver the signed license agreement to CDI with payment of the initial license fee. The requestor is then licensed. CDI will notify Coriell which entities are licensed, and licensed entities may request desired iPSC lines.
Are the license fees for a single iPSC line or for all the lines in the repository?
The Standard License Agreement for the CIRM hPSC Repository covers all the hPSC lines in the bank. The license fees are not per line, but for the entire bank.
Can my organization negotiate any of the terms of the license agreement?
No negotiation of the license terms will be offered for the license fee amounts stated in the Standard License Agreement for the CIRM hPSC Repository. If an organization wants to negotiate any of the terms of the license, CDI will enter into such negotiations, but additional license fees will apply.
Is there any reach-through claim on the license?
CDI, Coriell or CIRM will not claim ownership of a discovery that arises from the use of the iPSC line(s). For example, if the iPSC line(s) or derivatives of them are used in experiments that establish a new small molecule or protein drug candidate, that discovery is owned by the licensee. CDI has no claim on the discovery. On the other hand, if an activity requires continued use of iPSC line(s), such as making differentiated cells for use in fee-for-hire screening services, that activity requires both a license and the payment of royalties to CDI under the Standard License Agreement.
If my organization already has a license from iPS Academia Japan (iPS AJ), does my organization pay less fees or get a credit on their fees paid?
iPS AJ has informed CDI that as of August 2015, no entity has a license from iPS AJ that is as broad in the research tools space as the license rights available here. Any organization that wishes to explore what credits may be available to it because of an existing license from iPS AJ may contact CDI, but again additional license fees may apply. On the other hand, no organization should be required to pay royalties twice. If your organization is only doing activities licensed by iPS AJ, an adjustment for royalty fees will be given.