MAH Sample Clauses

MAH. The Drug Approvals in China currently held in the name of MMCO shall be transferred to the New Swiss MAH (“Drug Approval Transfer”) after the Swiss MA is transferred to the New Swiss MAH. Once the holder of the Swiss MA is changed from MMCO to the New Swiss MAH, CASI shall in connection with paragraph 1.4 below, take all necessary steps to submit the variations to the Drug Approvals in China for the Drug Approval Transfer and to reflect that the holder of the Drug Approvals in China is changed from MMCO to the New Swiss MAH. From 01 January 2024 through the Term, Acrotech, either directly or through the New Swiss MAH or its designated agent, shall be solely responsible for all maintenance costs, including filing fees and related attorneys’ fees as required, pertaining to the Swiss MA. In addition, CASI shall take all necessary steps (including the establishment of all persons and entities and related capabilities as are required under applicable Law) for the Relevant Drug Approval Transferee to fulfil the applicable obligations of local agent of the Drug Approvals in China. From the Assignment Effective Date through the Term, CASI shall be solely responsible for all maintenance costs, including filing fees and related attorneys’ fees as required, pertaining to the Drug Approvals in China. For the purpose of this Agreement, (a) MMCO, being MICL’s Affiliate holding the aforementioned Drug Approvals in China as of the Assignment Effective Date shall be referred to as “Relevant Drug Approval Holder”; and (b) CASI or its local Affiliate who will be appointed as local agent in China with respect to the aforementioned Drug Approvals in China shall be referred to as “Relevant Drug Approval Transferee”. In this paragraph 1, obligations of the Relevant Drug Approval Holder shall be read as obligations of MICL to procure that the Relevant Drug Approval Holder shall perform such obligations.
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MAH. (s) shall mean the Marketing Authorization Holder(s) that operate and place medicines on the market for sale in the European Economic Area and/or Switzerland.

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  • MALAYSIA Notifications

  • UNITED ARAB EMIRATES Notifications

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