Examples of Approved CMO in a sentence
Incyte shall be solely responsible, at its sole cost and expense, for Manufacturing from the Licensed Compound Bulk Drug Substance, itself or through an Approved CMO, [**] of the projected global commercial supply of the Licensed Compound Drug Product.
Amgen shall be responsible for all costs associated with the transition to Amgen (or to such Approved CMO) (including payment at the FTE Rate for hours of consulting support provided by Kite).
The Parties hereby agree that each Existing CMO is deemed to be an Approved CMO solely for performance of Manufacturing of Licensed Products and Components, as the case may be, within the scope of the applicable Existing CMO Agreement.
Kite shall also, in connection therewith, grant to such Approved CMO a non-exclusive license to use such manufacturing technology solely for the purposes of performing the transitioned manufacturing of Amgen Products for Amgen.
MTEM will not materially change any agreement with an Approved CMO as it relates to Supply, including any change to the criteria agreed upon by the Parties through the Joint Manufacturing Committee to which Supply should conform to be considered acceptable for its intended use, except in accordance with the Quality Agreement and otherwise subject to agreement of the Joint Manufacturing Committee.
In any event, Kite shall cooperate to provide to Amgen (or to such Approved CMO under obligations of confidentiality) all existing manufacturing information then in Kite’s possession and control and reasonably required for Amgen (or such Third Party) to perform such transitioned manufacturing of Amgen Products.
Notwithstanding anything in this Agreement to the contrary, LGC’s CMC information may only be shared with an Approved CMO.
Upon Vaxcyte’s reasonable request, made no earlier than [***] and no later than [***], Sutro shall support and cooperate with Vaxcyte to conduct an additional Tech Transfer to Vaxcyte, or an Affiliate of Vaxcyte or an Approved CMO designated by Vaxcyte, in a manner sufficient for Vaxcyte to fully exercise the Manufacturing Rights at the facilities of such designated recipient (the “Second Tech Transfer”).
Without limiting the generality of the foregoing, Sutro shall have no liability to Vaxcyte with respect to any losses to the extent arising from (A) implementation of any [***] by Vaxcyte or an Approved CMO (including [***]) on behalf of Vaxcyte, or (B) any claims of failure to supply, product quality or product liability arising from Extract Manufactured by Vaxcyte, its Affiliates or any Approved CMO (including [***]) pursuant to a direct contract between such Approved CMO and Vaxcyte or its Affiliates.
Describe the assignments and exercises that will be used to promote critical thinking, synthesis, and transfer Students utilize previous didactic and pre-clinical knowledge to provide care in diverse clinical environments to patients in underserved areas.