NISSO definition

NISSO means Nippon Soda Co., Ltd. which is the contract manufacturer of the Drug Substance for DSP.
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NISSO means Nippon Soda Co., Ltd., which is the contract manufacturer of the Drug Substance for Replidyne as of the Effective Date.
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Examples of NISSO in a sentence

  • After the initial NDA filing for the Product, if Forest transfers responsibility for manufacturing Drug Substance to a Third Party manufacturer in accordance with the API Supply Agreement, then, provided that NISSO and DAP are then in full compliance with the API Supply Agreement, [ *** ].

  • It is expressly understood that the Drug Master File for the Drug Substance shall be registered and controlled by DSP and/or NISSO and DSP and/or NISSO shall give a reference letter to the Regulatory Authorities in connection with REPLIDYNE’s efforts in seeking Regulatory Approvals and submitting any such applications, amendments, or supplements for Drug Products.

  • The Parties recognize that NISSO may demand Delay Compensation (hereinafter defined) in connection with continued supply of Drug Substance.

  • Replidyne shall have the right, in its sole discretion, to enforce or otherwise settle with NISSO and DAP the parties’ agreement regarding such refund.

  • DSP represents and warrants that, as of the Effective Date, NISSO has no contractual or other right to receive, or to request or expect to receive, any such Delay Compensation between DSP and NISSO except for DSP’s payment that becomes due on or before March 31, 2004.

  • Subject to Section 6.3, all costs incurred after October 1, 2005 related to manufacture, packaging and distribution of Drug Substance and Product will be borne by Forest; provided, however, that, with regard to validation batches of Drug Substance for which the parties may agree to pay NISSO and DAP in advance, subject to refund if such validation batches do not meet the specified requirements, [ *** ], Replidyne shall promptly [ *** ].

  • Notwithstanding anything that may be interpreted to the contrary in this Section 4.5, in no event will either Party be responsible for payment of any compensation to NISSO pursuant to this Section 4.5 unless it has individually approved the amount and timing of such compensation pursuant to negotiations and discussions among both Parties and NISSO.