2021.1.0

Nihonbashi Life Science Bldg. 6F, 2-3-11 Nihonbashi-Honcho, Chuo-ku, Tokyo 103-0023 JapanTel: +81-3-6262-1575　Fax: +81-3-6262-1576　E-mail: info@firm.or.jphttps://firm.or.jp

It was the Millennium Project planned by the Obuchi Cabinet in 1999 when the term "Saisei-Iryo” , or Regenerative medicine in English, made an appearance in Japan. Twenty years have passed since then. During that time, nine products were marketed as regenerative medicine products. Seven of these are cell-based, and two are gene therapy. In 2001, the Japanese Society for Regenerative Medicine, the largest academic association in the field of regenerative medicine in Japan, was established. The number of members now exceeds 6000 after approximately 20 years of the history. FIRM started in 2011, and 256 companies currently participate in the program. Do you think 20 years is a long or short time? Do you think these results over two decades are many or few? I think that you may have different impressions for each of them. Japan's related regulatory reforms in 2014 were also very important for regenerative medicine. The category "Regenerative Medicine products" was defined, and it was an opportunity to think about the characteristic content different from conventional pharmaceuticals and medical devices. Regenerative medicine requires diverse and complex modalities. In particular, those transplanted for tissue regeneration have the characteristics of both a "product" provided by companies and of a "medical procedure" provided by medical institutions. In order to develop regenerative medicine, in addition to how to develop these rationally, we must build a method to evaluate them appropriately, and then look for better ways to use them after use. “Regenerative Medicine Safety Assurance Act” and “Conditional and Time-Limited Approval” now receive a variety of opinions from overseas. However, this regenerative medicine contains many realistic contents from the perspective of a "product" and a "medical procedure." Currently, we are in the process of firmly appealing to the Japanese system of regenerative medicine. We believe the Japanese system has much to offer the model of regenerative medicine, so while we are taking into account the different viewpoints of international cooperation, we believe in the system and hope that regulation of regenerative medicine can become a major subject not only in Japan, but around the world a well. In this way, the biggest achievements over the last two decades may be all the contents we have discussed under the new category of regenerative medicine so far; Where to disclose as a cooperative area and where to compete. Even this cannot be considered in existing frameworks, as regenerative medicine is falsely similar to the conventional drugs and medical devices. What should an appropriate business model look like? All members of FIRM worked to conceive an unknown area of regenerative medicine after various discussions, literally without pay, together with the government and academia. We are convinced that this experience is essential for the future development of regenerative medicine in Japan.

We are currently being deprived of the connection among people by the threat of new coronavirus (COVID-19). The Earth, which has become smaller under globalization, also has the potential to change significantly through the prolongation of this influence. Needless to say, new and unique industries and cultures will also emerge. However, in order to develop the complex field of regenerative medicine, industry-academia-government collaboration, collaboration between companies, and cooperation between goods and technologies will not be born without a connection. I look forward to the return of our daily lives, where we can overcome this disaster and have discussions together in the future.

To Develop the Field of Japanese Regenerative Medicineinto a World-class Industry, by Strengthening Collaborationsamong Industries, Government, and Academia

Ken-ichiro Hata

Forum for Innovative Regenerative Medicine (FIRM)Representative Director, Chairperson

| Establishment | June 2011| Address | Nihonbashi Life Science Bldg. 6F, 2-3-11 Nihonbashi-Honcho, Chuo-ku, Tokyo 103-0023 Japan| Number of member companies (as of June 8, 2020) | 226 Regular members, 5 Special members, 23 Supporting members, 12 Individual members, 2 Honorary member | Board Directors |

Ken-ichiro Hata (Japan Tissue Engineering Co., Ltd.)

Nobuyuki Osakabe (Hitachi, Ltd.) Kunihiko Suzuki (MEDINET Co., Ltd.)

Mikitomo Yasutake (Asahi Kasei Corporation) Setsuko Hashimoto (CellSeed Inc.) Masayuki Yabuta (Daiichi Sankyo Co., Ltd.) Toshiki Sugimoto (Dai Nippon Printing Co., Ltd.) Junji Okada (FUJIFILM Corporation) Shosaku Murayama (iPS PORTAL, Inc.) Tatsuo Suzuki (JCR Pharmaceuticals Co., Ltd.) Yoshifumi Torii (Kyowa Kirin Co., Ltd.)

Tohru Hirose (Novartis Pharma K.K.) Yoshitake Saito (Olympus Corporation)Osamu Takahashi (PHC Corporation) Kazuya Omi (SRL, Inc.)Toru Kimura (Sumitomo Dainippon Pharma Co., Ltd.)Masanobu Kimura (TAKARA BIO INC.)Yasushi Kajii (Takeda Pharmaceutical Company Limited)Kazuhisa Senshu (TERMO CORPORATION)

Mitsuomi Shirahashi (iPS Academia Japan, Inc.)Hironao Yazaki (ERNST & YOUNG SHINNIHON LLC)

TopMessage

Representative Director, Vice Chairperson

Directors

Yoshitsugu Shitaka (Astellas Pharma Inc.)

Supervisory Board Members

Representative Director, Chairperson

Vice Chairperson

Outline of FIRM

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Regenerative medicine and cellular medicine promise new concepts of medical technology that cannot be provided by existing medicine and medical instruments. It is the intention of FIRM to provide the medical industry and patients who cannot find satisfaction with existing medical treatment with alternative medical technology. We will also work with the industry, government and universities to turn Japan into a world leader in regenerative medicine, to ensure that research results are quickly commercialized and aggressively pursue comprehensive measures to overhaul our social structure.

Introduction of FIRM

Objective

1. Provide solutions or advices of commercialization strategies on regenerative medicine2. Promote mutual exchange and cooperation between the people involved in regenerative medicine both in and out of Japan3. Conduct surveys and Statistical analyses for regenerative medicine 4. Host and organize research workshops and hold open lectures on regenerative medicine5. Conduct additional and related projects on regenerative medicine

Activities

Organization

Introductionof

FIRM

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General Meeting

Secretariat

Board of Directors

Steering Committee

Council for Steering Committee

Supervisory Board Member

Supporting Industries Committee

Cell and Gene Therapy Products Committee

Compliance Committee

Standardization Committee

Public Affairs Committee

International Affairs Committee

Education Implementation Committee

Publication Committee

Venture Establishment/Promotion Committee

Committee to Standardize Foundation forCell Characterization and Cell Production

ISO/TC 276 Japan Mirror Committee

Committee for Non-Clinical Safety Evaluationof Pluripotent Stem Cell-derived Product

Facility and Equipment Committee Materials Committee

Testing Committee Logistics Committee

Regulatory Committee Health Economics Committee

Regulatory Harmonization Committee Manufacturing Committee

Towards Commercialization of Regenerative Medicine

- Confirm and explain common terms and definitions

- Propose short-, medium-, long-term visions- Pro-active dissemination of information

- Cooperation with industry, academia, government, and private sector.

- International deliberations and proposals- Establish eco system for commercialization

FIRM’s initiativesto promote

regenerative medicine

■Social acceptance・Form public opinion・Cooperate with mass media・Provide correct information from patients’ perspective・Healthcare economics assessment

■Therapy expansion・Cost to establish business. Issues on insurances.・Form public opinion to people・Basic medicalization after ten years・Industrialize for global dissemination

Manufacturing

Launch and Sales

Clinical research

Basic research

Regenerative Medical products(Laws ensuring the quality effectiveness

and safety of medicine, regenerative instruments, etc.)

Approval(including the conditional and time limited authorization)

Application

Pharmaceuticalstrategy consultation

→ Clinical trials

Non-clinical research

■Issues from non-clinical research to clinical trials・Establish practical evaluation method of efficacy/ safety in non-clinical research・Establish proper evaluation method of clinical efficacy and its guide・Promote revision of biological materials

■Issues from non-clinical research to clinical trials・Establish practical evaluation method of efficacy/ safety in non-clinical research・Establish proper evaluation method of clinical efficacy and its guide・Promote revision of biological materials

■Human Resources/ Education Authorizing System・Improvement of culture accuracy・Operation and improvement of education system・Authorization by educational organization・Human resource education■Design procurement scheme of cell materials for

regenerative medicine・Necessity of mediating agencies for constant and stable collection/supply of human cell materials.

■Human Resources/ Education Authorizing System・Improvement of culture accuracy・Operation and improvement of education system・Authorization by educational organization・Human resource education■Design procurement scheme of cell materials for

regenerative medicine・Necessity of mediating agencies for constant and stable collection/supply of human cell materials.

■Support to applications for approvals・Edition and cooperation of sales

and manufacturing direction of cell and gene therapy products

・Prepare a guidebook to applications for approval/business license

・Prepare a checklist for application and approval

■Support to applications for approvals・Edition and cooperation of sales

and manufacturing direction of cell and gene therapy products

・Prepare a guidebook to applications for approval/business license

・Prepare a checklist for application and approval

(Act on the Safety of Regenerative Medicine)

■Issues on implementing under the Act on the Safety of Regenerative Medicine

・Establish standards and/or guides about quality assurance of specific processed cells

■Handling under current regulatory systems・Promote combination use of insurance covered/uncovered

therapies by utilizing the Advanced Medical Care・Comply with the newly executed Clinical Trials Act

■Issues on implementing under the Act on the Safety of Regenerative Medicine

・Establish standards and/or guides about quality assurance of specific processed cells

■Handling under current regulatory systems・Promote combination use of insurance covered/uncovered

therapies by utilizing the Advanced Medical Care・Comply with the newly executed Clinical Trials Act

■Manufacturing・Create value chains with organizing peripheral industries・Establish standards for equipment and services・Correspond to guidelines on GCTP

■Regenerative medicine products/IP・Know-how・Patent strategies combined with standardization・Support startups

■Post-marketing evaluation・Examine ideal ways of post marketing clinical trials/post marketing surveys・Utilize regenerative medicine patient registry system・Prepare a guidebook for reporting defect

■Issues on insurance application・Establish rules specific to regenerative medicine products Correspond to cost- effectiveness assessment (Health Technology Assessment)・Examine ideal pricing of regenerative medicine products

■Manufacturing・Create value chains with organizing peripheral industries・Establish standards for equipment and services・Correspond to guidelines on GCTP

■Regenerative medicine products/IP・Know-how・Patent strategies combined with standardization・Support startups

■Post-marketing evaluation・Examine ideal ways of post marketing clinical trials/post marketing surveys・Utilize regenerative medicine patient registry system・Prepare a guidebook for reporting defect

■Issues on insurance application・Establish rules specific to regenerative medicine products Correspond to cost- effectiveness assessment (Health Technology Assessment)・Examine ideal pricing of regenerative medicine products

■Standardization and Normalization・Establish a standardization strategy for Japan・Realize proposals at international venues.

Overview of FIRM History

20112015

2016

2017

2018

2019

June Established “The Forum for Innovative Regenerative Medicine (FIRM)” with 14 companies

March Opened the FIRM subsidiary office in Kansai area

Entered into Memorandum of Understanding (MOU) with The Alliance for Regenerative

Medicine (ARM) in the US

May Entered into MOU with Centre for Commercialization of Regenerative Medicine (CCRM) in Canada

for accelerating Regenerative Medicine

July Hosted the 1st “Regenerative Medicine Crossroad in Tokyo”

October Entered into MOU with The Council for Advanced Regenerative Medicine (CARM) in Korea for

accelerating Regenerative Medicine in both countries

Introduced the environments surrounding Regenerative Medicine in Japan at the workshop in

Cell & Gene Meeting on the MESA 2016

Hosted the 2nd “Regenerative Medicine Crossroad in Tokyo”

Cosponsored “Regenerative Medicine Japan” session in BioJapan 2016 with Japan

Bioindustry Association (JBA) and conducted four sponsored seminars

Cosponsored the 1st “Industry-Academia-Government Regenerative Medicine Symposium

November Cosponsored the “2016 World Alliance Forum in San Francisco”

Entered into MOU with China Medical Biotech Association (CMBA) in China

Hosted the 1st “Regenerative medicine venture supporting seminar”

December Received approval of ISO New Work Item Proposal on design process to establish

specification of cell transportation

February Hosted the 3rd “Regenerative Medicine Crossroad in Tokyo”

Hosted the 2nd “Regenerative medicine venture supporting seminar”

August Entered into MOU with Association of Biotechnology Led Enterprises (ABLE) in India

October Entered into MOU with AusBiotech in Australia

Cosponsored “Australia - Japan Regenerative Medicine Round Table”

Entered into MOU with Cell and Gene Therapy Catapult (CGT Catapult) in UK

Entered into MOU with International Society for Cell & Gene Therapy (ISCT) February Entered into MOU with Israel Stem Cell Society (ISCS) in Israel

April Hosted “The 1st Asia Partnership Conference of Regenerative Medicine Associations (APACRM)”

Entered into MOU with Biotechnology and Pharmaceutical Industries Promotion Office (BPIPO) in Taiwan

September Hosted the 8th “Regenerative Medicine Crossroad in Tokyo”

Hosted the 6th “Regenerative medicine venture supporting seminar”

April Hosted The 2 nd “APACRM” in Nihonbashi, Japan

June Hosted the 7th Plenary and combined WG meetings of ISO/TC 276 at Nihonbashi, Tokyo

August Hosted The 8th” Regenerative medicine venture supporting seminar” (Dec. The９th, 2020 Feb. The10th)September Hosted The 10th “Regenerative Medicine Crossroad” (2020 Feb. The 11th)October Hosted The Japan Session at Cell & Gene Meeting on the MESA 2019

In addition to the above, FIRM has made a number of proposals and public comments, hosted roundtable

discussions and seminars with government offices and affiliates, and through these activities, FIRM is

strengthening the cooperation between Regenerative Medicine organizations both in and out of Japan.

Overviewof

FIRM HistoryOur Global AlliancesOur

Global Alliances

1) ARM: Alliance for Regenerative Medicine2) BIA: UK Bio Industry Association3) CCRM: Center for Commercialization of Regenerative Medicine4) CARM: The Council for Advanced Regenerative Medicine

5) CMBA: China Medical Biotech Association 6) ABLE: Association of Biotechnology Led Enterprises7) ISCS: Israel Stem Cell Society8) ISCT: International Society for Cellular Therapy9) BPIPO: Biotech and Pharmaceutical Industries Program Office

To Promote Harmonization & Optimization of Regulations on RM Products among Asian Countries/Regions

> Sharing Information and Exchanging Opinions

> Building a Common View on Prospects & Challenges for/against RM

2018 Apr: The 1st APACRM. Agreed the objective promoting regulatory harmonization

2019 Apr: Decided creating WG to discuss more with each expertise

2019 Oct: WLM; Agreed concrete activity plan to do2020 : Cancellation The 3rd APACRM due to

COVID-192021 Apr: The 4th APACRM

History

Working Level Meeting

WG1 : To investigate the differences in non-clinical data packages required for Cellular Therapy Products in Asian countries/regions and to extract regulatory science issues & limitations

WG2 : Regulation on starting cells for cellular therapy products in Asian countries/regions and risk-based approach

1

Forum for Innovative Regenerative Medicine

FIRM Global Network

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Supporting Industries Committee・The Supporting Industries Committee discusses how the peripheral industries that support regenerative medicine

should be structured from the viewpoints of both suppliers and users, and then, in close cooperation with other

committees of FIRM, it creates an appropriate value chain that supports the peripheral industries.

・The committee has established specialized sub-Committees for four fields to drive the creation of each element of the

value chain, including “Facility and Equipment”, “Materials (including culture media, plasticware and consumables)”,

“Logistics,” and “Testing (equipment and reagents)”. Through these sub-committees’ activities, four FIRM’s original

standards and two case-studies have already been published as of April 1, 2020 (available only in Japanese).

・The committee places great importance on collaborating with Cell and Gene Therapy Products Committee and intends to develop

solutions for various problems related to manufacturing and transporting cell and gene therapy products thorough the collaboration.

・The committee works on developing and offering draft proposals of international standards originating from FIRM’s

standards in collaboration with the “Standardization Committee” and other committees.

Venture Establishment/Promotion Committee

Venture Establishment/Promotion Committee plays a key role as a point of contact for accelerated industrialization of regenerative medicine and gene/cell therapy in Japan. Venture Establishment/Promotion Committee responds to various inquiries and requests from domestic and international companies, venture enterprises, and academia relating to the development and commercialization of regenerative medical products and gene/cell therapy in Japan, and gives their best effort to help them resolve their bottlenecks and indecisions. Venture Establishment/Promotion Committee is committed to providing tactical and practical aid to allow leading-edge medical care technologies to swiftly reach ailing patients.

Committees Workingon Industry Challenges

CommitteesWorking

on IndustryChallenges

Committees Workingfor National Projects

CommitteesWorking for

NationalProjects

Standardization Committee・The Standardization Committee, established in April 2020, is working at its first task to promote the understanding

of FIRM members that standards are important to the business activities of each member company.

・In parallel with fulfilling this task, the Standardization Committee is tacking with its main subjects, i.e. 1) understanding

of the external environment (e.g. industrial policy, regulatory trends) to set standardization theme, 2) designing of

standardization strategies, and 3) promoting the utilization of standards.

Cell and Gene Therapy Products（CGTP’s） Committee【Mission】To achieve FIRM VISION 2025, organize issues and regulations on development, production, and sale of CGTP’s,

and clarify priorities and do activities.

【Role of Core-members’ meeting】Summarize issues of GCTP’s companies, draft concrete suggestion and proposal, and negotiate with regulatory

authorities so as to connect the issues to new-establishment and improvement.

【Role of Regulatory Committee】1. Consider and proposal the ideal way of regulation and system in proportion to the field in order to promote the

industrialization of regenerative medicine.

2. Facilitate industrialization by developing specific tools such as guidance required for current regulations and systems.

3. Correspond to seek opinions from regulatory authorities and among others.

【Role of Manufacturing Committee】1. Share and arrange issues in manufacturing sites among companies that develop and manufacture GCTP’s.

2. Establish standardization and commonization of production and quality control specific to regenerative medicine

with regulatory agencies through the activities of the expert committees by manufacturing companies.

3. Collaborate with supporting industry companies to realize regenerative medicine industrialization, and proposal for regulatory optimization.

4. Correspond to seek opinions from regulatory authorities and among others.

【Role of Health Economics Committee】1. Consider issues on health economics, and draft suggestion and proposal.

2. Correspond to seek opinions from regulatory authorities and among others.

【Role of Regulatory Harmonization Committee】1. Independently conduct APACRM (Asia Partnership Conference of Regenerative Medicine) activities in which

International Committee used to take the initiative.

2. Have discussions for regulatory harmonization.

ISO/TC 276 Japan Mirror CommitteeCommittee to Standardize Foundation for Cell Characterization and Cell Production

ISO/TC 276 (International Organization for Standardization Technical Committee 276) Biotechnology covers standardization in the field of biotechnology processes including analytical methods and bioprocessing, both of which are major challenges in industrializing regenerative medicine. FIRM organizes ISO/TC 276 Japan Mirror Committee and Committee to Standardize Foundation for Cell Characterization and Cell Production. Experts from academia, government and industry are actively participating in these committees to discuss how to promote industrialization of regenerative medicine through standards. FIRM members, with colleagues of Japan Mirror Committee, are playing major roles in developing standards related to regenerative medicine at ISO/TC 276. Firstly, they have led developments of ISO/TS 20399-1:2018 (ancillary materials present during the production of cells) and ISO 21973:2020 (transportation of cells) to publication, and they are currently developing several more projects. Secondly, their contributions are highly respected in ISO/TC 276, because they also provide valuable inputs to standardization projects led by experts from other countries. FIRM hosted the 7th ISO/TC 276 Plenary and Working group meetings in Nihonbashi, Tokyo, Japan in June 2019, where more than 100 experts from worldwide gathered for 6 days.

CoNCEPT (Committee for Non-Clinical Safety Evaluation of Pluripotent Stem Cell-derived ProducT)/MEASURE (Multisite Evaluation Study on Analytical Methods for Non-Clinical Safety Assessment of HUman-Derived REgenerative Medical Products)

The FIRM-CoNCEPT supports MEASURE, which is an AMED-granted Study led by Dr. Yoji Sato at National Institute of Health Sciences, to achieve its goal. The mission of CoNCEPT/MEASURE is to provide regulatory science-based globally acceptable consensus for safety evaluation policy in the R&D of pluripotent stem cell-derived products. Especially, validated methods for tumorigenicity evaluation, which are in alignment with regulatory direction and international standard, will be developed through multi-institutional joint research.

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Forum for Innovative Regenerative Medicine Members as of June 8, 2020

IKARI SHODOKU CO.,LTD.

Ikeda Scientific, Co., Ltd.

intellim Corporation

iPS Academia Japan, Inc.

iPS PORTAL, Inc.

Ipsos Healthcare Japan Limited

IQVIA Services Japan K.K.

ITOCHU CHEMICAL FRONTIER Corporation

Iwatani Corporation

Janssen Pharmaceutical K.K.

Japan Tissue Engineering Co., Ltd.

JCR Pharmaceuticals Co., Ltd.

JFE Techno-Research Corporation

JMS CO,.LTD

JSR Corporation

JTEC CORPORATION

KAITO CO., LTD.

Kaken Pharmaceutical Co., Ltd.

KANEKA CORPORATION

KANTO CHEMICAL CO., INC.

Kao Corporation

KATAOKA CORPORATION

Kiko Tech Co., Ltd.

Kohjin Bio Co., Ltd.

KOKEN CO., LTD.

Kondoh Industries, Ltd.

KURARAY CO., LTD.

KYOCERA Corporation

Kyokuto Pharmaceutical Industrial Co., Ltd.

KYORIN Pharmaceutical Co., Ltd.

Kyowa Kirin Co., Ltd.

LIFEBANK Japan, INC.

Life Science Institute, Inc.

Life Technologies Japan K.K.

Lonza Japan Ltd.

Lymphocyte-bank Co.,Ltd.

Macrobiosis Inc.

MARUBISHI BIOENGINEERING Co., Ltd.

Maruho Co., Ltd.

MATRIXOME, Inc.

MEDINET Co., Ltd.

MEDIPAL HOLDINGS CORPORATION

Megakaryon Corporation

Meiji Seika Pharma Co., Ltd.

Merck Ltd.

Metcela Inc.

METRAS, Inc.

MICRON Inc.

micronix Co., Ltd.

MIKASA SEIYAKU CO., LTD.

Mitsubishi Chemical Corporation

MITSUBISHI GAS CHEMICAL COMPANY,INC.

MITSUBISHI LOGISTICS CORPORATION

Mitsui Chemicals, Inc.Mitsui Fudosan Co., Ltd.

Mitsui Sumitomo Insurance Company, Limited

Mitsui-soko Holdings Co., Ltd.

MIURA CO.,LTD

MOCHIDA PHARMACEUTICAL CO., LTD.

MOROO Inc.

Myoridge Co. Ltd.

Nard institute, LTD.

Nexredge Inc.

NICHIREI BIOSCIENCES INC.

NIHON KOHDEN CORPORATION

NIHON PHARMACEUTICAL CO., LTD.NIKON CORPORATION

Nippi, Incorporated

Nippon Becton Dickinson Company, Ltd.

Nippon Express Co.,Ltd.

NIPPON SHOKUBAI Co.,LTD

NIPRO CORPORATION

Nissan Chemical Corporation

NISSIN CORPORATION

NISSUI PHARMACEUTICAL CO., LTD.

NITTA Corporation

North American Science Associates Japan G.K.

Novartis Pharma K.K.

NSK Ltd.

NTN Corporation 　NTT DATA INSTITUTE OF MANAGEMENT CONSULTING, Inc.

Olympus Corporation

Optima Inc.

Organ Technologies Inc.

Osaka Sanitary Co.,Ltd.

Otsuka Pharmaceutical Co., Ltd.

Otsuka Pharmaceutical Factory, Inc.

Panasonic Environmental Systems & Engineering Co., Ltd.

PAREXEL International Inc.

PERSOL TEMPSTAFF CO.,LTD.

Pfizer Japan Inc.

Pharma Solutions Co., Ltd.

PharmaBio Corporation

PHC Corporation

POC Clinical Research Inc.

RAYMEI INC.

ReproCELL Inc.

RION CO., LTD.

Roche Diagnostics K.K.

ROHTO Pharmaceutical Co., Ltd.

Rorze Lifescience Inc.

SanBio Company Limited

SANKEN SETSUBI KOGYO CO.,LTD.

SANKI Engineering Co., Ltd.

SANPLATEC CORP.

Saraya Co., Ltd.

SAROUTE Co., Ltd.

Sartorius Stedim Japan K.K.

SCREEN Holdings Co., Ltd.

SD Biosystem Co.,Ltd.

Seed Planning, Inc.

SEIKEN CO.,LTD.

SEKISUI SEIKEI, LTD.

Senko Medical Logistics Co.,Ltd.

SHIBAMATA TRANSPORT Co.,Ltd.

SHIBUYA KOGYO CO., LTD.

Shimadzu Corporation

SHIMIZU CORPORATION

SHIN NIPPON AIR TECHNOLOGIES CO., LTD.

Shin Nippon Biomedical Laboratories, Ltd.（SNBL)

Shiseido Company, Limited

SMC Corporation

Sompo Japan Nipponkoa Insurance Inc.

SRD Co., Ltd.

SRL, Inc.

Sumitomo Bakelite Co., Ltd.

SUMITOMO CHEMICAL Co., Ltd.

Sumitomo Dainippon Pharma Co., Ltd.

Sumitomo Mitsui Banking Corporation

SUZUKEN CO., LTD.

SYSMEX CORPORATION

TAISEI CORPORATION

Taisho Pharmaceutical Co., Ltd.

TAIYO NIPPON SANSO CorporationTAKARA BIO INC.

Takasago Thermal Engineering Co., Ltd.

Takeda Pharmaceutical Company Limited

Takenaka Corporation

Teijin Limited　TEIJIN PHARMA LIMITED

Tella Pharma Inc.

TERUMO CORPORATION

Tokio Marine & Nichido Fire Insurance Co., Ltd.

TOMITA PHARMACEUTICAL CO.,LTD.

TOPPAN PRINTING CO., LTD.

TOSOH CORPORATION

Toyo Seikan Group Holdings, Ltd.

Trust Express Co., Ltd.

UniBio Corporation

Vision Care Inc.

VITAL KSK HOLDINGS, INC..

WAKENBTECH CO.,LTD.

Wanbishi Archives Co., Ltd.

YAMATO LOGISTICS CO.,LTD．Yokogawa Electric Corporation

Yokohama BioResearch & Supply, Inc.

ZENOAQ RESOURCE CO., LTD.

ZIMMER BIOMETZIMMER BIOMET

A2 Healthcare Corporation

ADEKA CORPORATION

Advanced Cell Technology and Engineering Ltd.

Advantec kensyusenta

AGC Inc.

Airex Co.,Ltd.

AIRTECH JAPAN, LTD.

AJINOMOTO CO., INC.

Alfresa Corporation

Alfresa Holdings Corporation

Amano Enzyme Inc.

AMBICION Co., Ltd.

Anderson Mori & Tomotsune

AnGes, Inc.

API Co.,Ltd.

Asahi Kasei Corporation

Astellas Pharma Inc.

bioMerieux Japan Ltd.

BIOMIMETICS SYMPATHIES Inc.

BrightPath Biotherapeutics Co., Ltd.

Celgene K.K.

Cell Exosome Therapeutics Co, Ltd.

Cell Science & Technology Institute Inc.

CellBank Corp.

CellGenTech, Inc.

CellSeed Inc.

CellSource Co., Ltd.

CHIYODA CORPORATION

Chiyoda TechnoAce Co.,Ltd.

chromocenter Inc.

Chugai Pharmaceutical Co., Ltd.

CMIC Co., Ltd.

Corning International K.K.

COSMO BIO CO., LTD.

Covance Japan Co., Ltd.

Cyfuse Biomedical K.K.

DAEWOONG PHARMACEUTICAL CO.,LTD.

Dai Nippon Printing Co., Ltd.

DAI-DAN CO,.LTD.

Daiichi Sankyo Co., Ltd.

DAIKIN INDUSTRIES, LTD.

Denka Co., Ltd.

Drug Safety Testing Center Co., Ltd.

Earth Environmental Service Co., Ltd.

Eil Inc.

Eisai Co., Ltd.

EPS Corporation

ESPEC　CORP.

Evonik Japan Co., Ltd.

FUJIFILM Corporation

FUJIFILM Wako Pure Chemical Corporation

Fujimori Kogyo Co.,Ltd.

FUJISOFT INCORPORATED

FUJISOFT Tissue Engineering Co., Ltd.

FUKOKU CO., LTD.

Funakoshi Co.,Ltd.

GC LYMPHOTEC Inc.

Global Life Sciences Technologies Japan

Grandsoul Research Institute for Immunology, Inc.

HEALIOS K.K.

Heartseed Inc.

Hitachi Chemical Co.,Ltd.

Hitachi Plant Services Co., Ltd.

Hitachi, Ltd.

HITACHIZOSEN　CORPORATION

ID Pharma Co., Ltd.

iHeart Japan Corporation

IHI Corporation

Central Institute for Experimental Animals

Foundation for Biomedical Research and Innovation at Kobe

Japan Blood Products Organization

Japan Food Research Laboratories

Naito Medical Clinic

Fuyuhiko Mori

Fumiaki Hirata

Junzo Koike

Kazuhiro Takekita

Kenji Maekawa

Masato Deguchi

Mime Egami

Nakatsugu Yaginuma

Naoki Watanabe

Rika Tanaka

Toshihiro Horiuchi

Zen-ichi Mohri

Toichi Takenaka

Yuzo Toda

Air Liquide Japan Ltd

AIS Co., Ltd.

ANTI-AGEING Co,.Ltd.

Century Medical, Inc.

COREFRONT Corporation

Cytori Therapeutics K.K.

Dojindo Laboratories

EELS(Edogawa Evolutionary Laboratory of Science)

ERNST & YOUNG SHINNIHON LLC

Human Life CORD Japan Inc.

INABATA&CO.,LTD.

JTB Communication Design, Inc.

KAN Research Institute, Inc.

Kirin Holdings Company, Limited

Mizuho Securities Co., Ltd.

MUTOH CO., LTD.

Nikon CeLL innovation Co., Ltd.

Nobelpharma Co., Ltd.

RADIA INDUSTRY CO., LTD.

RICOH COMPANY, LTD.

SunFlare Co., Ltd.

TEC Project Services Corporation

Toshiba Corporation

V

IKARI SHODOKU CO.,LTD.

Ikeda Scientific, Co., Ltd.

intellim Corporation

iPS Academia Japan, Inc.

iPS PORTAL, Inc.

Ipsos Healthcare Japan Limited

IQVIA Services Japan K.K.

ITOCHU CHEMICAL FRONTIER Corporation

Iwatani Corporation

Janssen Pharmaceutical K.K.

Japan Tissue Engineering Co., Ltd.

JCR Pharmaceuticals Co., Ltd.

JFE Techno-Research Corporation

JMS CO,.LTD

JSR Corporation

JTEC CORPORATION

KAITO CO., LTD.

Kaken Pharmaceutical Co., Ltd.

KANEKA CORPORATION

KANTO CHEMICAL CO., INC.

Kao Corporation

KATAOKA CORPORATION

Kiko Tech Co., Ltd.

Kohjin Bio Co., Ltd.

KOKEN CO., LTD.

Kondoh Industries, Ltd.

KURARAY CO., LTD.

KYOCERA Corporation

Kyokuto Pharmaceutical Industrial Co., Ltd.

KYORIN Pharmaceutical Co., Ltd.

Kyowa Kirin Co., Ltd.

LIFEBANK Japan, INC.

Life Science Institute, Inc.

Life Technologies Japan K.K.

Lonza Japan Ltd.

Lymphocyte-bank Co.,Ltd.

Macrobiosis Inc.

MARUBISHI BIOENGINEERING Co., Ltd.

Maruho Co., Ltd.

MATRIXOME, Inc.

MEDINET Co., Ltd.

MEDIPAL HOLDINGS CORPORATION

Megakaryon Corporation

Meiji Seika Pharma Co., Ltd.

Merck Ltd.

Metcela Inc.

METRAS, Inc.

MICRON Inc.

micronix Co., Ltd.

MIKASA SEIYAKU CO., LTD.

Mitsubishi Chemical Corporation

MITSUBISHI GAS CHEMICAL COMPANY,INC.

MITSUBISHI LOGISTICS CORPORATION

Mitsui Chemicals, Inc.Mitsui Fudosan Co., Ltd.

Mitsui Sumitomo Insurance Company, Limited

Mitsui-soko Holdings Co., Ltd.

MIURA CO.,LTD

MOCHIDA PHARMACEUTICAL CO., LTD.

MOROO Inc.

Myoridge Co. Ltd.

Nard institute, LTD.

Nexredge Inc.

NICHIREI BIOSCIENCES INC.

NIHON KOHDEN CORPORATION

NIHON PHARMACEUTICAL CO., LTD.NIKON CORPORATION

Nippi, Incorporated

Nippon Becton Dickinson Company, Ltd.

Nippon Express Co.,Ltd.

NIPPON SHOKUBAI Co.,LTD

NIPRO CORPORATION

Nissan Chemical Corporation

NISSIN CORPORATION

NISSUI PHARMACEUTICAL CO., LTD.

NITTA Corporation

North American Science Associates Japan G.K.

Novartis Pharma K.K.

NSK Ltd.

NTN Corporation 　NTT DATA INSTITUTE OF MANAGEMENT CONSULTING, Inc.

Olympus Corporation

Optima Inc.

Organ Technologies Inc.

Osaka Sanitary Co.,Ltd.

Otsuka Pharmaceutical Co., Ltd.

Otsuka Pharmaceutical Factory, Inc.

Panasonic Environmental Systems & Engineering Co., Ltd.

PAREXEL International Inc.

PERSOL TEMPSTAFF CO.,LTD.

Pfizer Japan Inc.

Pharma Solutions Co., Ltd.

PharmaBio Corporation

PHC Corporation

POC Clinical Research Inc.

RAYMEI INC.

ReproCELL Inc.

RION CO., LTD.

Roche Diagnostics K.K.

ROHTO Pharmaceutical Co., Ltd.

Rorze Lifescience Inc.

SanBio Company Limited

SANKEN SETSUBI KOGYO CO.,LTD.

SANKI Engineering Co., Ltd.

SANPLATEC CORP.

Saraya Co., Ltd.

SAROUTE Co., Ltd.

Sartorius Stedim Japan K.K.

SCREEN Holdings Co., Ltd.

SD Biosystem Co.,Ltd.

Seed Planning, Inc.

SEIKEN CO.,LTD.

SEKISUI SEIKEI, LTD.

Senko Medical Logistics Co.,Ltd.

SHIBAMATA TRANSPORT Co.,Ltd.

SHIBUYA KOGYO CO., LTD.

Shimadzu Corporation

SHIMIZU CORPORATION

SHIN NIPPON AIR TECHNOLOGIES CO., LTD.

Shin Nippon Biomedical Laboratories, Ltd.（SNBL)

Shiseido Company, Limited

SMC Corporation

Sompo Japan Nipponkoa Insurance Inc.

SRD Co., Ltd.

SRL, Inc.

Sumitomo Bakelite Co., Ltd.

SUMITOMO CHEMICAL Co., Ltd.

Sumitomo Dainippon Pharma Co., Ltd.

Sumitomo Mitsui Banking Corporation

SUZUKEN CO., LTD.

SYSMEX CORPORATION

TAISEI CORPORATION

Taisho Pharmaceutical Co., Ltd.

TAIYO NIPPON SANSO CorporationTAKARA BIO INC.

Takasago Thermal Engineering Co., Ltd.

Takeda Pharmaceutical Company Limited

Takenaka Corporation

Teijin Limited　TEIJIN PHARMA LIMITED

Tella Pharma Inc.

TERUMO CORPORATION

Tokio Marine & Nichido Fire Insurance Co., Ltd.

TOMITA PHARMACEUTICAL CO.,LTD.

TOPPAN PRINTING CO., LTD.

TOSOH CORPORATION

Toyo Seikan Group Holdings, Ltd.

Trust Express Co., Ltd.

UniBio Corporation

Vision Care Inc.

VITAL KSK HOLDINGS, INC..

WAKENBTECH CO.,LTD.

Wanbishi Archives Co., Ltd.

YAMATO LOGISTICS CO.,LTD．Yokogawa Electric Corporation

Yokohama BioResearch & Supply, Inc.

ZENOAQ RESOURCE CO., LTD.

ZIMMER BIOMETZIMMER BIOMET

A2 Healthcare Corporation

ADEKA CORPORATION

Advanced Cell Technology and Engineering Ltd.

Advantec kensyusenta

AGC Inc.

Airex Co.,Ltd.

AIRTECH JAPAN, LTD.

AJINOMOTO CO., INC.

Alfresa Corporation

Alfresa Holdings Corporation

Amano Enzyme Inc.

AMBICION Co., Ltd.

Anderson Mori & Tomotsune

AnGes, Inc.

API Co.,Ltd.

Asahi Kasei Corporation

Astellas Pharma Inc.

bioMerieux Japan Ltd.

BIOMIMETICS SYMPATHIES Inc.

BrightPath Biotherapeutics Co., Ltd.

Celgene K.K.

Cell Exosome Therapeutics Co, Ltd.

Cell Science & Technology Institute Inc.

CellBank Corp.

CellGenTech, Inc.

CellSeed Inc.

CellSource Co., Ltd.

CHIYODA CORPORATION

Chiyoda TechnoAce Co.,Ltd.

chromocenter Inc.

Chugai Pharmaceutical Co., Ltd.

CMIC Co., Ltd.

Corning International K.K.

COSMO BIO CO., LTD.

Covance Japan Co., Ltd.

Cyfuse Biomedical K.K.

DAEWOONG PHARMACEUTICAL CO.,LTD.

Dai Nippon Printing Co., Ltd.

DAI-DAN CO,.LTD.

Daiichi Sankyo Co., Ltd.

DAIKIN INDUSTRIES, LTD.

Denka Co., Ltd.

Drug Safety Testing Center Co., Ltd.

Earth Environmental Service Co., Ltd.

Eil Inc.

Eisai Co., Ltd.

EPS Corporation

ESPEC　CORP.

Evonik Japan Co., Ltd.

FUJIFILM Corporation

FUJIFILM Wako Pure Chemical Corporation

Fujimori Kogyo Co.,Ltd.

FUJISOFT INCORPORATED

FUJISOFT Tissue Engineering Co., Ltd.

FUKOKU CO., LTD.

Funakoshi Co.,Ltd.

GC LYMPHOTEC Inc.

Global Life Sciences Technologies Japan

Grandsoul Research Institute for Immunology, Inc.

HEALIOS K.K.

Heartseed Inc.

Hitachi Chemical Co.,Ltd.

Hitachi Plant Services Co., Ltd.

Hitachi, Ltd.

HITACHIZOSEN　CORPORATION

ID Pharma Co., Ltd.

iHeart Japan Corporation

IHI Corporation

Central Institute for Experimental Animals

Foundation for Biomedical Research and Innovation at Kobe

Japan Blood Products Organization

Japan Food Research Laboratories

Naito Medical Clinic

Fuyuhiko Mori

Fumiaki Hirata

Junzo Koike

Kazuhiro Takekita

Kenji Maekawa

Masato Deguchi

Mime Egami

Nakatsugu Yaginuma

Naoki Watanabe

Rika Tanaka

Toshihiro Horiuchi

Zen-ichi Mohri

Toichi Takenaka

Yuzo Toda

Air Liquide Japan Ltd

AIS Co., Ltd.

ANTI-AGEING Co,.Ltd.

Century Medical, Inc.

COREFRONT Corporation

Cytori Therapeutics K.K.

Dojindo Laboratories

EELS(Edogawa Evolutionary Laboratory of Science)

ERNST & YOUNG SHINNIHON LLC

Human Life CORD Japan Inc.

INABATA&CO.,LTD.

JTB Communication Design, Inc.

KAN Research Institute, Inc.

Kirin Holdings Company, Limited

Mizuho Securities Co., Ltd.

MUTOH CO., LTD.

Nikon CeLL innovation Co., Ltd.

Nobelpharma Co., Ltd.

RADIA INDUSTRY CO., LTD.

RICOH COMPANY, LTD.

SunFlare Co., Ltd.

TEC Project Services Corporation

Toshiba Corporation

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