Manufacturing Transfer Plan definition
Examples of Manufacturing Transfer Plan in a sentence
Once agreed, the Manufacturing Transfer Plan shall be incorporated herein by reference, and the Parties will execute on the Manufacturing Transfer Plan.
No Manufacturing Transfer Plan shall require Takeda to assume any CMO Supply Agreements between Denali and its Third Party Provider for Manufacturing activities for the relevant Collaboration Program unless Takeda consents to do so.
Following the transfer contemplated by the Manufacturing Transfer Plan, Licensee shall ensure that the supply of the Product Manufactured by or on behalf of Licensee and its Affiliates that is introduced into the market for sale in the Field in the Territory meets all quality standards required by Applicable Law, including cGMP.
Without limiting the foregoing, after completion of the Manufacturing Transfer Plan, Denali shall, and shall use Commercially Reasonable Efforts to [***], provided that Denali shall use Commercially Reasonable Efforts to Confidential 52 *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission.
In the event the assignment of any such CMO Supply Agreement is conditioned (other than for notice), the Parties shall discuss such conditions in good faith and, if the Parties, mutually agree to satisfy such conditions for the assignment of the applicable CMO Supply Agreement, the Manufacturing Transfer Plan shall address such matter.
Notwithstanding anything to the contrary in this Agreement, each Manufacturing Transfer Plan and any Manufacturing Technology Transfer shall be subject to the terms and conditions of the agreements between the Manufacturing Lead and its applicable Third Party Providers of manufacturing services and technology (each agreement, a “CMO Supply Agreement”).
In such instance, Denali shall, in accordance with the applicable Manufacturing Transfer Plan, [***].
Without limiting the foregoing, Takeda shall not become the Manufacturing Lead with respect to any Collaboration Program until the completion of the applicable Manufacturing Transfer Plan.
The Manufacturing Transfer Plan shall include [***]the following terms: (i[***] before Manufacturing of the Product for the Licensed Territory is fully transitioned from EyePoint to Alimera, and agreement by the Parties on updated forecasts and other terms under this Agreement to enable such transition; (ii) agreement on [***] terms to wind down and terminate this Agreement, including [***]; and (iii) a technology transfer plan[***].
The Manufacturing Transfer Plan shall be reviewed and approved by the JMC within [***] ([***]) [***] after the JMC is established, and may be amended from time to time by the JMC, provided that in all cases the Manufacturing Transfer Plan shall minimize the risk of disruption to the supply of Existing Antibody and Existing Products for use in any Phase III Clinical Study.