Clinical Grade Captisol

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