Approved CMO definition
Examples of Approved CMO in a sentence
Each sublicense granted to an Approved CMO or Approved Contractor pursuant to this Section 2.3(b) shall be granted pursuant to a written agreement between the Approved CMO or Approved Contractor and Vaxcyte that [***].
In the event that Sutro purchases frozen liquid Extract from an Approved CMO or Vaxcyte in respect of the foregoing clause (A), or from [***] in respect of the foregoing clause (B), Sutro shall first reimburse Vaxcyte for [***]; provided, that for clarity, Sutro shall not be obligated to reimburse Vaxcyte for [***].
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.
Vaxcyte shall provide to Sutro copies of the applicable contractual provisions in such agreement related to protection of Sutro’s intellectual property with such Approved CMO or Approved Contractor, and shall [***].
Notwithstanding anything in this Agreement to the contrary, LGC’s CMC information may only be shared with an Approved CMO.
Notwithstanding anything to the contrary in the License Agreement, nothing in the License Agreement shall require Vaxcyte to provide Sutro notice or obtain Sutro’s consent (or otherwise restrict Vaxcyte’s rights) in respect of the exercise of the Manufacturing Rights under (and in accordance with the terms of) this Agreement (including the Manufacture of Extract and [***] by an Approved CMO).
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.
Kite shall use diligent efforts either to have its contract with such Approved CMO (if such Approved CMO is a Kite CMO) with respect to such Amgen Product (and potentially other Amgen Products) assigned to Amgen, or facilitate discussions between Amgen and such Approved CMO with respect to a new contract to be entered into between them with respect to continued supply of such Amgen Product for Amgen’s further supply needs.
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.