Commercial Grade Captisol

Example Definitions of "Commercial Grade Captisol"
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.
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 and (d) meets the Specifications. Product.
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 intended for use in humans, (c) is intended for commercial sale of the Licensed Product and (d) meets the Specifications. Product.
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Commercial Grade Captisol. Defined in the Commercial License Agreement
Commercial Grade Captisol. Defined in the Commercial License Agreement
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Commercial Grade Captisol. Captisol which (i) has been manufactured under GMP conditions, (ii) is intended for use in humans, and (iii) is intended for commercial sale of the Licensed Products.
Commercial Grade Captisol. Means CAPTISOL which (a) has been manufactured in accordance with the cGMPs and meets the Specifications for Commercial Grade CAPTISOL, (b) is intended for use in humans, and (c) is intended for manufacturing the Licensed Product for commercial sale.
Commercial Grade Captisol. Means [***]. For clarity, Commercial Grade Captisol shall meet the specifications set forth in Exhibit B.
Commercial Grade Captisol. Captisol which [***]
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. 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.
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