(Ver.07/6/2024)

The Japanese version of this document is the authoritative version, and this English translation isintended for reference purposes only. Should any discrepancies or doubts arise between the twoversions, the Japanese version shall prevail.

Review criteria for evaluating requests to use the iPS Cell Stock
1.

Contents of the research plan or project should be in conformity with the file “Basicpolicies for supply of the iPS cell stock.”2.

Contents of the research plan or project should have received approval by theappropriate board for ethical requirements in conformity with related laws andregulations※1.

3.

Collaborative research agreements for use of the iPS cell stock should be signed
between research institutions and the CiRA Foundation. If the CiRA Foundation
terminates the collaborative research agreement due to infringement of theagreement, etc., the research institutions are not allowed to use the iPS cell stock
thereafter in principle.

4.

The research institutions should have personnel with knowledge and experience ofhandling iPS cells and iPS cell products and be well equipped for handling them.

5.

Using the iPS cell stock for clinical use requires a past record of performance of
culturing, refrigerating, thawing and inducing the differentiation of thecorresponding iPS cell stock for research use※2 (see iPS Cell Stock List), besides
satisfying the requirements stated in item 6※1. However, this condition shall not
apply if there is a sufficient amount of desired iPS cell stock for clinical use and thesaid stock falls under any of (1) or (2) or (3) below.

(1) When there are adequate past records of performance using the CiRA
Foundation’s iPS cell stock for clinical use, a past record of performance using theCiRA Foundation’s iPS cell stock for research is not necessarily required.
(2) When the preparation to carry out clinical research and clinical trials (hereinafterreferred as to as “clinical research, etc.”) has sufficiently progressed and theInstitute’s iPS cell stock for clinical use is necessary to carry out non-clinicalresearch to apply the said clinical research, etc., item 6 is not necessarily required.
In this case, however, the use shall be limited to only non-clinical use.
(3) In the case of an MCB (master cell bank) of the clinical-grade iPS cell stock※3(Ver.07/6/2024)

having been produced at sufficient quantity, the applicant does not necessarilyneed to have used research-grade cells. However, in this case, the use shall belimited to non-clinical use or the manufacturing of cell banks.
6.

When the iPS cell stock is used for clinical research, the iPS cell stock should beprocessed by specified cell product manufacturers in conformity with the Japan Act
on the Safety of Regenerative Medicine (Act No. 85 of 2013). When the iPS cellstock is used for clinical trials, differentiated cells should be produced in cellprocessing facilities in conformity with Good Manufacturing Practices (GMP) for
Investigational Products (or the Japan Ministerial Ordinance of Good Gene,Cellular, and Tissue-based Products Manufacturing Practice (GCTP)).

※1

Applications for the iPS cell stock may be examined before applicantssatisfy the requirements, but supply of the stock shall happen only after
fulfillment of the requirements.
※2

This stock was previously called “for non-clinical use”.

※3 iPS cell lines sufficiently analyzed and expanded to use as raw material
for regenerative medicine products