BULK DRUG SUBSTANCE Clause Samples
The BULK DRUG SUBSTANCE clause defines the requirements and standards for the active pharmaceutical ingredient (API) used in the manufacture of a drug product. It typically outlines specifications for quality, purity, and source of the bulk drug substance, and may detail responsibilities for testing, documentation, and approval prior to use in production. This clause ensures that only qualified and compliant bulk drug substances are used, thereby safeguarding product quality and regulatory compliance.
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BULK DRUG SUBSTANCE. (BDS) shall mean the active compound, alfimeprase, as set forth in the Development Plan and/or Project Plan, to be supplied by NUVELO for use in Production or Development of Drug Product.
BULK DRUG SUBSTANCE. Subject to the following, Aradigm shall be responsible for securing a supply of bulk ANALGESIC DRUGS for inclusion in DRUG PRODUCTS. Such supply will be obtained from suppliers holding current drug establishment registrations and DRUG MASTER FILES with FDA and similar foreign regulatory agencies and appropriate current licenses from the U.S. Drug Enforcement Administration and from similar foreign regulatory agencies. In the event that SB can obtain the bulk supply of a particular ANALGESIC DRUG on terms more favorable than Aradigm is able to obtain, then SB may contract to obtain the bulk supply to be provided to Aradigm at SB's cost; provided that if SB obtains such bulk supply pursuant to a contractual arrangement with the supplier that grants SB exclusive rights to such supply, SB covenants that [ * ] in the event of termination of this Agreement in its entirety pursuant to Section 2.6, 5.5, 14.2 (due to the uncured breach by SB), or 14.3, and provided further that if the Agreement terminates as to * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
BULK DRUG SUBSTANCE. Subject to the terms of this Agreement, during the Term Abbott shall manufacture or cause to have manufactured all Product requested by Triangle.
BULK DRUG SUBSTANCE. Amgen shall have the right at anytime, upon written notice to Purchaser, to transition the formulation, fill and finish manufacturing activities of Drug Product to an alternate source pursuant to this Section 2.14 (Alternate Supply). In the event Amgen transitions only the formulation, fill and finish manufacturing activities of Drug Product to an alternate source pursuant to this Section 2.14 (Alternate Supply), then thereafter Amgen’s obligations under this Agreement with respect to Drug Product shall instead apply only with respect to Bulk Drug Substance, as applicable and appropriate, and the provisions hereunder applicable to Drug Product shall instead apply to Bulk Drug Substance, as applicable and appropriate. In such event, the Parties shall promptly meet to establish a forecasting and order procedure applicable to Bulk Drug Substance, and the forecasting and order procedure set forth in Section 2.2 (Forecasts and Orders) shall no longer apply.