Clinical Grade Captisol definition

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.

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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 for clinical trials for the Licensed Product.

Clinical Grade Captisol means [***]

Examples of Clinical 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.

• 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.

• Sage shall have, subject to the terms and conditions of this Agreement, the right to purchase Clinical Grade Captisol and/or Commercial Grade Captisol from CyDex, at the purchase prices specified in Exhibit A hereto, as may be increased pursuant to Section 4.1(a); such purchase prices are EXW (Incoterms 2010) CyDex’s production point or storage facilities.

More Definitions of Clinical Grade Captisol

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 [***]. “Commercial Grade Captisol” means [***].

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> or any successor thereto, (b) is intended for use in humans, and (iii) is intended for clinical trials for the Product.

Clinical Grade Captisol means [***]. For clarity, Clinical Grade Captisol shall meet the specifications set forth in Exhibit B.

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.

Clinical Grade Captisol. “Commercial Grade Captisol”, “Commercial Launch Date”, “Commercially Reasonable Efforts”, “Compound”, “Contract Manufacturer”, “FDA”, “Field”, “Licensed Product”, “NDA”, “Pfizer” “Specifications”, and “Sublicensees” are defined in the Commercial License Agreement.

Clinical Grade Captisol means Captisol which (a) has been manufactured under conditions of cGMPs, (b) is intended for use in humans, and (c) is intended for clinical trials for