Manufacturing Transfer Date definition
Examples of Manufacturing Transfer Date in a sentence
If Vertex determines that such supply will be needed prior to the Manufacturing Transfer Date, then, at Vertex’s request, the Parties will negotiate and enter into a clinical supply agreement (the “Supply Agreement”) and a quality agreement regarding such clinical supply on commercially reasonable terms.
Following the Manufacturing Transfer Date and except as set forth in the Research Plan or any Additional Research Plan, Vertex will have sole and exclusive control over all matters related to the Manufacture and supply of Licensed Agents and Products for Exploitation in the Field in the Territory.
Prior to the Manufacturing Transfer Date, Company will have the sole responsibility to Manufacture and supply to Vertex quantities of ENTR-701 reasonably requested by Vertex for Development activities at Vertex’s cost and expense.
Upon the Manufacturing Transfer Date, Beta may Manufacture or have Manufactured the Glucagon Products for its and its Affiliates’ and Sublicensees’ requirements for Commercialization in the Field in the Territory in accordance with the terms and conditions set for the in the Commercial Supply Agreement.
Without limiting the foregoing, Xeris hereby expressly retains the right under the Xeris Technology to (a) perform the Xeris Development Activities for the Glucagon Products in the Territory in accordance with the Development Plan, (b) Manufacture the Glucagon Products in the Territory until the Manufacturing Transfer Date, (c) Manufacture the Reformulated Glucagon for use outside the Field, and (d) perform Xeris’ other obligations under this Agreement.
Subject to the terms and conditions of this Agreement, commencing upon the Manufacturing Transfer Date, Xeris, on behalf of itself and its Affiliates, hereby grants to Beta an exclusive, non-transferrable (except to the extent permitted under Section 13.1 (Assignment)) license under the Xeris Technology that is necessary or reasonably useful for the Manufacture of the Glucagon Products in the Field in the Territory solely to Manufacture the Glucagon Products in the Field in the Territory.
Santhera shall be free to decide, in its discretion, whether to maintain, after the Manufacturing Transfer Date, capabilities to Manufacture or have Manufactured the Compound and the Product for territories other than the Territory.
In addition, at Otsuka’s reasonable request prior to the Manufacturing Transfer Date, Perception will provide assistance and one or more technology transfer(s) to Otsuka or its designee of information (including test methods for Clinical Sample QA/QC) necessary or reasonably useful to support Otsuka’s acceptance activities and, if applicable, secondary packaging of Clinical Samples, and for Otsuka to fulfill quality management responsibilities relating to Clinical Samples and [***].
For clarity, the terms of this Section 6 shall only apply prior to the Manufacturing Transfer Date.
Until the Manufacturing Transfer Date, Perception or its CMO shall also provide to Otsuka [***], (i) the open part of the DMF, such as the sections containing general information, control of drug substance, container closure system, and stability, (ii) [***].