Basic ethical policy on allogeneic cultured products
Japan Tissue Engineering Co., Ltd.
1. Purpose
Allogeneic cultured products are regenerative medical products made by culturing cells provided by someone
other than the patient who is to receive the treatment (hereinafter referred to as “allogeneic human tissue, etc.”).
“Basic ethical policy on allogeneic cultured products” (hereinafter referred to as “this basic ethical policy”)
stipulates the matters with which our company must comply in the product development of allogeneic cultured
products (including clinical research and clinical trials), their manufacture and post-marketing management, andother related activities (hereinafter referred to collectively as “product supply activities”), from an ethical viewpoint.
Our company has established and complies with this basic ethical policy in order to ensure respect for the
goodwill of the cell donors and the protection of their personal information, as well as to ensure the safety of theproducts for patients, and occupational safety for workers in the spirit of maintaining human dignity and respect forhuman rights.

2. Responsibilities as a corporation
Our corporate philosophy is to “contribute to improved quality of life for patients through industrialization ofregenerative medicine”. By fulfilling the following responsibilities in product supply activities for allogeneic cultured
products, we are sincerely accepting and responding to the demands and expectations of society.
1. We ensure the human rights of donors and the safety of patients by conducting product supply activities forallogeneic cultured products in compliance with laws, ordinances, and related standards.
2. We show respect for the goodwill of donors and endeavor to recycle the goodwill of donors back into societythrough product supply activities for allogeneic cultured products.
3. We make efforts to spread information on product supply activities for allogeneic cultured products so as togain the understanding of society.
4. We strive to ensure occupational safety through a facility environment that gives consideration to biosafety
while at the same time preventing contamination from the external environment.

3. Role of the Ethics Committee
We have established an ethics committee (hereinafter referred to as the “J-TEC Ethics Committee”) in order todevelop our business in a manner consistent with socially accepted standards, including ethical values, and we
respect the opinions of the committee.
The J-TEC Ethics Committee reviews the ethical validity of this basic ethical policy and confirms that productsupply activities for allogeneic cultured products are conducted in compliance with this basic ethical policy.

4. General principles in the handling of allogeneic human tissue, etc.
1. Explanations for donors
We ask the medical institution that collects allogeneic human tissue, etc. (hereinafter referred to as the“collection facility”) to obtain advance consent for donation of allogeneic human tissue, etc. from the donor orfrom a legal representative* if it is difficult for the donor to give informed consent, after providing a sufficient
explanation of the necessary matters.
2. Respect for free will
We show the greatest respect for the free will of the donor when obtaining consent for donation of allogeneic
human tissue, etc.**

3. Principle of uncompensated donation
As in blood donation, allogeneic human tissue, etc., is donated out of goodwill, and the donor does not profit
from donation.
1. Limitation on purposes of use
Allogeneic human tissue, etc. is used only for the purpose that was explained to the donor in advance and isnever appropriated to other uses.
2. Revocation of consent
Within the time window during which revocation of consent is possible, donors can still revoke consent evenafter donating allogeneic human tissue, etc.** If the donor revokes consent, we will dispose of the donatedallogeneic human tissue, etc., appropriately. However, results that have already been obtained cannot bedestroyed.
<Note>*The legal representative is the person who is judged most capable of representing the wishes and interest of thedonor, and it may be a person with parental authority, a spouse, a guardian, or other similar party.
**Persons who do not consent to donation of allogeneic human tissue, etc. and donors who revoke consent will
not be disadvantaged in medical treatment.

5. Acceptance of allogeneic human tissue, etc.
We accept surgically* removed unnecessary allogeneic human tissue, etc. from appropriate collection facilities.
In addition to the legally required explanation, donors are provided with a full explanation of the purpose of use,
the time window during which consent can be revoked, and the handling of personal information, etc. through thecollection facility.**<Note>*In this case, “surgery” refers only to operations performed as treatment, and does not refer to operations
performed to harvest allogeneic human tissue, etc., or to surgery for which the surgical plan has been changed (toextensive resection, etc.).
**This section stipulates that allogeneic human tissue, etc. can only be accepted after the purpose for which themanufactured allogeneic cultured products will be used has been explained to the donor in advance.

6. Construction of cell banks
J-TEC constructs the cell banks* needed in production supply activities for allogeneic cultured products, using
donated allogeneic human tissue etc.
In the construction of cell banks, we ensure product safety and occupational safety by evaluating the suitability of
the allogeneic human tissue, etc. through testing methods selected on the basis of the latest findings. Allogeneic
human tissue, etc. that is not confirmed to be suitable is properly disposed of.
<Note>*As indicated in the preceding notes, “cell bank” in this basic ethical policy refers to the cell bank constructed as
the raw material for the intended allogeneic cultured product. The cells in the cell bank are not genetically modified
through gene transfer, etc.

7. Product development of allogeneic cultured products
We conduct product development of allogeneic cultured products within the scope of the purpose of use explained
to the donor in advance. Allogeneic human tissue, etc. is not used for other purposes.
In clinical research and clinical trials of allogeneic cultured products, the ethical appropriateness of the clinicalresearch or clinical trial is reviewed in advance by the ethics committee, etc. of the clinical site.

8. Manufacture and post-marketing management of allogeneic cultured products
J-TEC has established criteria based on laws and ordinances related to manufacture and quality control. We
manufacture allogeneic cultured products in accordance with these criteria and release only those allogeneic
cultured products that meet the release criteria. Moreover, we make continued efforts in the areas of quality
control and quality improvement for allogeneic cultured products, based on the obtained data.
J-TEC has also established safety control criteria based on laws and ordinances. We collect information on thesafety of allogeneic cultured products in accordance with these criteria and take the greatest care to prevent
health injuries from occurring. In the unlikely event of a health injury, arrangements have been made to report it tothe related organizations immediately and take the necessary action.

9. Handling of information
All information obtained in product supply activities for allogeneic cultured products is properly managed, andevery effort is made to prevent it from being leaked.
The information obtained from collection facilities is limited to that which is necessary in product supply activities
for allogeneic cultured products and does not include information that could identify the donors. In the unlikely
event that there is an unexpected problem with an allogeneic cultured product and it becomes necessary to obtain
information about a donor from a medical institution, due consideration will be given to the strict management ofthat information.
<Note>
This stipulation includes results of tests performed on allogeneic human tissue, etc., other information obtained in
product supply activities, and content that our company is prohibited from disclosing at the request of the donor.
However, submitting information on allogeneic human tissue, etc. and allogeneic cultured products to regulatory
authorities in connection with an application for marketing approval for allogeneic cultured products, pursuant to
the law, is not prohibited.

10. Other
Allogeneic human tissue, etc. that has been harvested overseas is also handled in accordance with this basic
ethical policy. However, matters to which this basic ethical policy does not apply for reasons of differences in therelated legal regulations or bioethics of the country involved, will be reviewed by the J-TEC Ethics Committee afteras much related information as possible has been obtained from the country involved.

Established: March 7, 2015 (Effective: March 7, 2015)
Revised: September 24, 2015 (Effective: September 24, 2015)