Commercial Grade Captisol definition

Commercial Grade Captisol means Captisol which (a) has been manufactured under conditions of current good manufacturing practices for bulk excipients as set forth in U.S. Pharmacopoeia <1078> as of the Effective Date or any successor thereto, (b) is intended for use in humans, (c) is intended for commercial sale of the Licensed Product and (d) meets the Specifications.

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Commercial Grade Captisol means [***].

Commercial Grade Captisol means Captisol which (a) has been manufactured under conditions of current good manufacturing practices for bulk excipients as set forth in U.S. Pharmacopoeia <1078> as of the Effective Date or any successor thereto, and (b) is for commercial sale of the Licensed Product.

Examples of Commercial Grade Captisol in a sentence

Purchases of Captisol may include Research Grade Captisol, Clinical Grade Captisol and/or Commercial Grade Captisol.
Each purchase order, for all grades of Captisol, shall specify: (i) the grade of Captisol ordered (i.e., Commercial Grade Captisol or Clinical Grade Captisol); (ii) quantities; (iii) delivery dates; and (iv) reasonable shipping instructions.
Each purchase order, for all grades of Captisol, shall specify: (i) the grade of Captisol ordered (i.e., Commercial Grade Captisol, Clinical Grade Captisol or Research Grade Captisol); (ii) quantities; (iii) delivery dates; and (iv) reasonable shipping instructions.
Together with each Detailed Forecast provided under Section 3.2(b), Company shall place a firm purchase order with CyDex in a form mutually agreed upon by the parties, for Company’s order of Commercial Grade Captisol for Q1 delivery consistent with the Detailed Forecast.
Each purchase order, for all grades of Captisol, shall specify: (i) the grade of Captisol ordered (i.e., Commercial Grade Captisol or Clinical Grade Captisol); (ii) quantities; (iii) delivery dates; and (iv) reasonable shipping instructions and packaging requirements.

More Definitions of Commercial Grade Captisol

Commercial Grade Captisol means Captisol which (a) has been manufactured under GMP conditions, (b) is intended for use in humans, and (c) is intended for commercial sale of the Licensed Product.

Commercial Grade Captisol means Captisol® brand sulfobutylether ß(beta) cyclodextrin, sodium salt which (a) has been manufactured under GMP conditions, (b) is intended for use in humans, and (c) is intended for commercial sale of the Licensed Products.

Commercial Grade Captisol means Captisol which [***].

Commercial Grade Captisol means CAPTISOL which (a) has been manufactured under conditions of current good manufacturing practices for bulk excipients as set forth in U.S. Pharmacopoeia (1078) as of the Effective Date or any successor thereto, (b) is intended for use in humans, and (c) is intended for commercial sale of the Licensed Product.

Commercial Grade Captisol means [***]. *** 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. EXECUTION COPY

Commercial Grade Captisol means Captisol® brand sulfobutylether b (beta) cyclodextrin, sodium salt which (a) has been manufactured in accordance with the Specifications under GMP conditions, (b) is intended for use in humans, and (c) is intended for commercial sale of the Licensed Products. For the sake of clarity, engineering and regulatory qualification batches of Licensed Products shall be deemed “Commercial Grade Captisol” batches. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

Commercial Grade Captisol means Captisol which (a) has been manufactured under conditions of cGMPs,