Captisol Data Package definition
Captisol Data Package means (a) all toxicology/safety and other relevant scientific safety data owned, licensed or developed by CyDex and its Affiliates; and (b) all toxicology/safety and other relevant scientific data owned, licensed or developed by the licensees or sublicensees of CyDex or its Affiliates or other third parties (to the extent permitted in the applicable license or other agreements between CyDex and/or its Affiliates and such licensees, sublicensees or other third parties), in each case on Captisol alone (and not in conjunction with a product formulation).
Captisol Data Package means (a) all toxicology/safety and other scientific data owned, licensed or developed by CyDex and its Affiliates; and (b) all toxicology/safety and other scientific data owned, licensed or developed by the licensees or sublicensees of CyDex or its Affiliates or other Third Parties (to the extent permitted to be shared under this Agreement in the applicable license or other agreements between CyDex and/or its Affiliates and such licensees, sublicensees or other Third Parties), in each case of Captisol alone (and not in conjunction with a product formulation).
Captisol Data Package means (a) all toxicology/safety and other relevant scientific safety data owned, licensed or developed by CyDex and its Affiliates relating to Captisol; (b) all toxicology/safety and other relevant scientific data owned, licensed or developed by the licensees or sublicensees of CyDex or its Affiliates or other Third Parties (to the extent permitted in the applicable license or other agreements between CyDex and/or its Affiliates and such licensees, sublicensees or other Third Parties); and (c) the open portion of the DMF for Captisol®, in each case to the extent relating to Captisol® alone (and not in conjunction with a product formulation).
Examples of Captisol Data Package in a sentence
Without limiting the generality of the foregoing, CyDex’s Confidential Information includes all materials provided as part of the Captisol Data Package.
Sage may not sublicense its rights to the Captisol Data Package, except as expressly set forth in Section 2.3 and Section 2.4 below.
Without limiting the generality of the foregoing, CyDex’s Confidential Information includes all materials provided as part of the Captisol Data Package, and Sage’s Confidential Information includes Sage Patents and Sage Know-How.
Company may not sublicense its rights to the Captisol Data Package, except as expressly set forth in Sections 2.3 and 2.4 below.
Without limiting the generality of the foregoing, CyDex’s Confidential Information includes all materials provided as part of the Captisol Data Package and Product Know-How.
More Definitions of Captisol Data Package
Captisol Data Package means (a) all toxicology/safety and other relevant scientific data owned, licensed or developed by CyDex and its Affiliates relating to Captisol; and (b) all toxicology/safety and other relevant scientific data owned, licensed or developed by the licensees or sublicensees of CyDex or its Affiliates or other third parties (to the extent permitted in the applicable license or other agreements between CyDex and/or its Affiliates and such licensees, sublicensees or other third parties), in each case relating to Captisol alone (and not in conjunction with a product formulation).
Captisol Data Package means (a) all toxicology/safety and other relevant scientific safety data owned, licensed or developed by CyDex and its Affiliates; and (b) all toxicology/safety and other relevant scientific safety data owned, licensed or developed by the Portions of this Exhibit, indicated by the ▇▇▇▇ “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. licensees or sublicensees of CyDex or its Affiliates or other third parties (to the extent permitted in the applicable license or other agreements between CyDex and/or its Affiliates and such licensees, sublicensees or other third parties), in each case on Captisol alone (and not in conjunction with a product formulation).
Captisol Data Package means ****.
Captisol Data Package means (a) the DMF/CEP for Captisol, (b) all toxicology/safety and other relevant scientific safety data owned, licensed to or developed by CyDex and/or its Affiliates; and (c) all toxicology/safety and other relevant scientific safety data owned, licensed to or developed by the licensees or sublicensees of CyDex and/or its Affiliates and/or other third parties (to the extent permitted in the applicable license or other agreements between CyDex and/or its Affiliates and such licensees, sublicensees or other third parties), in each case on Captisol alone (and not in conjunction with a product formulation). [***]
Captisol Data Package means (a) all toxicology/safety and other relevant scientific safety data owned, licensed or developed by CyDex and its Affiliates; (b) all toxicology/safety and other relevant scientific data owned, licensed or developed by the licensees or sublicensees of CyDex or its Affiliates or other third parties (to the extent permitted in the applicable license or other agreements between CyDex and/or its Affiliates and such licensees, sublicensees or other third parties) on CAPTISOL alone (and not in conjunction with a product formulation); and (c) all CMC and manufacturing process data relating to the preparation of CAPTISOL, in each case to the extent necessary or useful for the formulation of the Licensed Product. For purposes of clarity, "CAPTISOL Data Package" shall include all dossier of data and information on CAPTISOL provided by CyDex under the Limited Clinical Use Agreement, including without limitation Material Safety Data Sheets, certificates of analysis, information on material stability and storage conditions, packaging, specifications, test methods, reference standards, and re-evaluation dates for CAPTISOL as well as known or expected adverse events related to the use of CAPTISOL.
Captisol Data Package means ****. GDSVF&H\1743342.4 LICENSE AND SUPPLY AGREEMENT PAGE 1 ****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. ****
Captisol Data Package means (a) all toxicology/safety and other scientific data owned, licensed or developed by CyDex and its Affiliates; and