Examples of Collaboration IND in a sentence
Subject to the ownership provisions of Sections 5.1, 5.3 and 6.1, Corvus shall own all right, title and interest in and to the Collaboration IND and related Regulatory Documentation.
Any amendments to the Protocol shall be reviewed and approved by Genentech in accordance with Section 3.1. Subject to the terms of this Agreement, Corvus shall be responsible for preparing and filing all necessary Regulatory Documentation for the Collaboration IND and the Study.
The Protocol for such Collaboration IND is set forth in Exhibit A.
Genentech shall provide to Syndax those portions of the investigator’s brochure (and any updates) for the Genentech Compound that pertain to safety information and are necessary to submit or amend the Collaboration IND or to conduct the Study.
Promptly after the Effective Date, and during the Study, each Party shall provide a Right of Cross-Reference to the existing IND for its Compound to the extent necessary to allow the Study to be conducted under the Collaboration IND.
For the avoidance of doubt, the Collaboration IND will not be a combination IND.
Kite will be responsible for fulfilling all regulatory reporting obligations with regard to the Study and the Collaboration IND and such requirements will be documented in the PV Agreement.
Promptly, but no later than ten (10) business days, after the Effective Date, Humanigen shall provide to Kite a letter of cross-reference authorizing Kite to reference Humanigen INDs for the Humanigen Investigational Product as reasonably necessary to support the Study under the existing Collaboration IND maintained by Kite.
The Protocol for such Collaboration IND is to be mutually agreed to by the JDC and based on the Kite protocol synopsis set forth in Exhibit A.
The Party who is designated to be Lead Party, as the sponsor of record of the Combined Therapy Collaboration IND shall prepare, file, maintain and solely own all Regulatory Documentation (including the applicable Combined Therapy Collaboration IND) associated with the Combined Therapy Collaboration IND.