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.
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

  • 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 delivery consistent with the Detailed Forecast.

  • At least 4 months before the first order of Commercial Grade Captisol, Sage shall deliver to CyDex a detailed good-faith rolling forecast setting forth Sage’s requirements and anticipated delivery schedules for Commercial Grade Captisol for the 12 month period following such first order (the “Initial Detailed Forecast”).

  • CyDex shall not be obligated to accept such orders to the extent that the quantities of Commercial Grade Captisol ordered exceed the Purchase Volume Limitations, but CyDex shall **** fill such orders for such excess quantities (provided that such quantities are less than the Volume Threshold) from available supplies.

  • CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.respect to the quantities of Captisol ordered that do not exceed the Purchase Volume Limitations, and (z) shall notify Company of CyDex’s ability to fill any quantities of such purchase order for Commercial Grade Captisol that are in excess of the Purchase Volume Limitations (but under the Volume Threshold) within **** after CyDex’s receipt of such purchase order.

  • 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 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 (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 2012 Effective Date or any amendment or successor thereto, (b) is intended for use in humans, and (c) is intended for commercial sale of any Licensed Product.
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 Captisol which (a) has been manufactured under conditions of cGMPs,
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.