Current Formulation definition
Current Formulation means the [***] and any other formulation of a Licensed Product used for any clinical or non-clinical study set forth on Schedule 1.44.
Current Formulation means Valrubicin at a concentration of 40 mg/ml in 50% Cremophor(R) EL (polyoxyethyleneglycol triricinoleate)/ 50% dehydrated alcohol or other formulations that are accepted by the FDA without the regulatory requirement for a formal clinical study to be submitted in support of such change in formulation.
Current Formulation means the approved formulations of Cimzia® (including the formulations for lyophilized vials, pre-filled syringes and the autoinjector) existing as of the Effective Date, each as described in the relevant approved BLAs existing as of the Effective Date.
Examples of Current Formulation in a sentence
Otsuka will have the right to elect whether Perception (through its CMO(s)) Manufactures and supplies API or Clinical Samples and whether any such Clinical Samples will be supplied in the form of bulk vials of Product in the Current Formulation (without labeling) or finished Product in the Current Formulation.
The initial Development Plan for the Current Formulation shall be submitted by Otsuka to the JCC for approval in accordance with Section 3.1.7 within [***] after the Effective Date.
The Parties will use good faith efforts to implement any such assignments requested by Otsuka in accordance with such schedule in order for Otsuka to procure Clinical Samples in the Current Formulation directly from such CMO(s).
More Definitions of Current Formulation
Current Formulation means the formulation of nimodipine microspheres, including the drug substance, biodegradable polymer as described further in the table below: Quantities Based upon Batch Sizes of: Weight Ingredient [**] [**] (%) [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
Current Formulation means any intravenous formulation of a Product for infusion existing as of the Effective Date.
Current Formulation means REDACTED (y) "CTA" means Clinical Trial Application in Canada. (z) "Development" means, in respect of each country in the Territory, work conducted under the Development Plan and as set out in Section 2.3 for the Indication up to the issuance of an Approval Letter in each such country for a Product in the Field. (aa) "Development Costs" means REDACTED (bb) "Development Plan" means the detailed plan(s) related to the research and the development (including work to obtain Governmental Approvals, including Marketing Authorizations), for RSD1235 in its Current Formulation for the Indication in the Field in the Territory, including the Phase III Studies and all supporting pre-clinical work, chemistry and manufacturing necessary to conduct the Phase III Studies, the technical transfer and manufacturing scale up and approval of a commercial manufacturing process, and to secure NDA Approval and the budget therefor as amended from time to time by the JDMC pursuant to which the Parties shall conduct the Development under the terms of this Agreement. The Development Plan for the United States and Canada is attached hereto as Exhibit 1.1(bb). (cc) "Effective Date" means the date whereupon all the requirements of Sections 15.1(a), 15.1(b), 15.1(c) and 15.1(d) have been met, provided that neither Party has terminated this Agreement prior to such requirements being met pursuant to Section 15.3. (dd) "Executive Summary" shall mean a report containing the information related to a Phase III Study that is described in Exhibit 1.1(dd). (ee) "FDA" means the United States Food and Drug Administration in the United States and any other comparable, applicable administrative agency in any other country in the Territory, or any successor entity thereto. (ff) "FHI Know How" means REDACTED
Current Formulation means [REDACTED: formulation of Product as of October, 2003]