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  • In order to accelerate the launch process of new IVD devices and reagents of Ortho in China market, the two parties plan to reach a deep strategic partnership.
  • This cooperation is executed through a joint venture. Two parties plan to establish Shanghai Ortho Medconn Biotechnology Ltd. (tentative name, which is subject to the approval and registration of SAMR, hereinafter referred to as the "Joint Venture") with a registered capital of CNY 2 million. Each party holds 50% of the registered capital.
  • The Joint Venture may be affected by elements including industry policies, market environment and business management in the future operation. There is a possibility that the research, development and operation of Joint Venture may not be as good as parties' expectation. This cooperation will not have a significant impact on the Company's financial position and operating results for the current year.
  • The cooperation is subject to anti-monopoly review on concentration of undertakings by the SAMR, and there is uncertainty in the implementation process. The Company will actively follow the progress of the matter and fulfill its information disclosure obligations in a timely manner. The Company respectfully request investors to make cautious decisions and pay attention to investment risks.

1. Summary

Since Shanghai Runda Medical Technology Co., Ltd. (hereinafter referred to as "the Company" or "Runda Medical") and Ortho-Clinical Diagnostics (hereinafter referred to as "Ortho-Clinical") have been working closely and well together for many years and in order to accelerate the launch process of Ortho-Clinical's new IVD devices and reagents in China market, the two parties plan to reach a deep strategic partnership.

Recently, Shanghai Medconn Biotechnology Co., Ltd. ("Medconn Biotech"), a wholly-owned subsidiary of the Company, and Ortho Biotechnology Development (Shanghai) Co., Ltd. ("Ortho Biotech"), a wholly-owned subsidiary of Ortho in China, entered into a Strategic Cooperation and Joint Venture Agreement to establish the Joint Venture with a registered capital of CNY 2 million. The Company plans to contribute CNY 1 million with its own capital, accounting for 50% of the registered capital of the Joint Venture.

The Joint Venture will develop IVD reagents for Ortho VITROS® immunodiagnostic analyzers (including but not limited to Ortho VITROS 3600, 5600 and 7600 instruments) that meet the requirements of the China market. All intellectual property rights in any type formed during the research and development process will be vested in the Joint Venture. The Company will also provide its own production capacity and promotion channels to fulfil the needs for commissioned production and product promotion of the Joint Venture.

Pursuant to the articles of association and relevant documents, this external investment is not required to be submitted to the board of directors and shareholders' meeting for deliberation.

This external investment is not a connected transaction or a major asset reorganization.

2. Basic Information of the Cooperation Agreement

(1) Basic Information of the Cooperation Partner

Name of Partner: Ortho Biotechnology Development (Shanghai) Ltd.

Enterprise Type: Limited Liability Company (Wholly Owned by a Foreign Legal Person)

Legal Representative: Yan Lin

Registered Capital: USD 1.1 million

Main Business: Ortho is one of the pioneer companies in the field of global IVD, serving the global clinical laboratory and transfusion medicine. Ortho Biotech is an important innovation platform outside of Research and Development Center of Ortho headquarter. Ortho Biotech focuses on technology development and services in the field of biotechnology and medical devices.

Except the issues disclosed in this announcement, the Company does not have any relationship with Ortho Biotech in terms of property rights, business, assets, debts and staff.

Ortho Biotech was established in April 2021 as a wholly owned subsidiary of Ortho-Clinical Diagnostics.

(2) Date, Place and Manner of Signing the Agreement

The Company signed the Strategic Cooperation and Joint Venture Agreement (hereinafter referred to as the "Agreement") with Ortho Biotech on January 17, 2022 in Shanghai.

(3) Basic Information of the Joint Venture

Name of the Joint Venture: Shanghai Ortho Medconn Biotechnology Ltd. (which is subject to the approval and registration of SAMR)

Registered Capital: CNY 2 million

Capital Contribution: Each party contributes CNY 1 million in the form of money, each accounting for 50% of the registered capital.

Enterprise Type: Limited Liability Company

Business Scope: Engaged in activities including technology services, technology development, technology consulting, technology exchange, technology transfer, technology promotion (except human stem cells, gene diagnosis and treatment technology development and application) in the field of biotechnology and pharmaceutical science (detailed business scope shall be subject to the approval of SAMR).

3. The Main Content of This Cooperation

Party A: Ortho Biotechnology Development (Shanghai) Co., Ltd.

Party B: Shanghai Medconn Biotechnology Co., Ltd.

The parties bilaterally agree to establish a joint venture (the "Joint Venture" or the "New Company") to develop IVD reagents for the Ortho VITROS® immunodiagnostic analyzers (including, but not limited to, the Ortho VITROS 3600, 5600 and 7600 instruments) that fulfil the needs of the China market. All intellectual property rights in any type formed during the research and development process will be vested in the Joint Venture.

(1) Personnel Arrangement for the Board of Directors, Supervisors and Management

1. The Joint Venture shall have a board of directors consisting of four directors. Each party shall appoint two directors respectively. The board of directors shall have a chairman, and one of the directors appointed by Party A shall be the chairman.

2. The Joint Venture shall not have a supervisory board, and each party shall appoint a supervisor.

3. The general manager, as the legal representative of New Company, of the Joint Venture shall be nominated by Party B. The chief financial officer and chief quality officer of the Joint Venture shall be appointed by Party A.

(2) The Rights and Obligations of the Parties

I. Party A

I) Party A is responsible for coordinating all aspects of support for the Joint Venture and the cooperation project from Ortho. Party A shall also promote the good development of the Joint Venture on behalf of Ortho.

II. Party B

I) Party B is responsible for coordinating all aspects of support for the Joint Venture and the cooperation project from Runda Medical. Party B shall also promote the good development of the Joint Venture on behalf of Runda Medical.

II) Party B is responsible for coordinating financial, manufacturing, distribution, construction, transportation and other related resources to help promote the good development of the Joint Venture.

III) Party B is responsible for providing its own production capacity or coordinating the production capacity of affiliated companies to fulfil the needs of the commissioned production of the Joint Venture to the best of its efforts.

IV) Party B is responsible for providing its own distribution channels or coordinating the distribution channels of affiliated companies and making its best efforts to increase the market share of the JV's products.

V) Party B is responsible for leading the declaration of concentration of undertakings for the proposed transaction under this Agreement (if required).

(3) Effectiveness of the Agreement

If the proposed transaction under this Agreement requires declaration of concentration of undertakings, both parties shall cooperate with each other to complete the declaration as soon as possible and submit the application for registration of the Joint Venture as soon as possible after obtaining unconditional approval from the Antimonopoly Bureau. If such unconditional approval of declaration cannot be obtained within four months after the signing of this Agreement, either party is entitled to terminate this Agreement.

4. Impact on the Listed Company

The execution of this Agreement is Ortho's recognition of the Company's abilities including its research capability, development capability, production capacity and comprehensive market competitiveness in IVD market, as well as the Company's development direction and strategy. This cooperation will help the Company to upgrade its research and development capability and production capacity to a higher international system standard. The cooperation will also help the Company to provide customers with diversity and good quality choices of IVD product by taking advantage of current comprehensive service platform.

5. Risk Warning

The Joint Venture may be affected by elements including industry policies, market environment and business management in the future operation. There is a possibility that the research, development and operation of Joint Venture may not be as good as parties' expectation. This cooperation will not have a significant impact on the Company's financial position and operating results for the current year.

The cooperation is subject to anti-monopoly review on concentration of undertakings by the SAMR, and there is uncertainty in the implementation process. The Company will actively follow the progress of the matter and fulfill its information disclosure obligations in a timely manner. The Company respectfully request investors to make cautious decisions and pay attention to investment risks.

This announcement is hereby made.

Shanghai Runda Medical Technology Co. Ltd.

Board of Directors

January 18, 2022

The Board of Directors of the Company and all the directors guarantee that there is no false record, misleading statement or material omission in the content of the announcement, and assume individual and joint responsibility for the truthfulness, accuracy and completeness of the content.

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Ortho Clinical Diagnostics Holdings plc published this content on 24 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 24 January 2022 21:45:01 UTC.