Genentech Compound definition
Examples of Genentech Compound in a sentence
Notwithstanding the foregoing, Arvinas shall not submit for publication or presentation any paper or presentation that includes information relating to any Licensed PROTACs or Licensed Products that contain a Genentech Compound without the prior written consent of Genentech.
Except for the foregoing or as otherwise expressly provided in the Agreement (e.g., Genentech’s obligation to supply the Genentech Compound under Section 4.2), or agreed to in writing by the Parties, *** shall be *** responsible for the costs of the Study.
Syndax shall require the Participating Sites to (i) maintain accurate records of all Genentech Compound received and dispensed in the conduct of the Study and (ii) properly store all Genentech Compound in accordance with any written instructions provided by Genentech and in a secure and locked location to prevent theft or misuse.
Genentech shall ensure that any Genentech Compound supplied under this Agreement has, at the time of delivery, an adequate remaining shelf life to meet the Study requirements.
The DRC shall be composed of (i) at least one clinician designated by Genentech familiar with the therapeutic profile of the Genentech Compound; (ii) at least one clinician designated by Syndax familiar with the therapeutic profile of the Syndax Compound; and (iii) if the Parties agree to include one or more independent clinicians, such individuals shall be acceptable to both Parties, and shall be bound by appropriate confidentiality obligations.
Genentech shall have the right (but not the obligation) to participate in any discussions with a Regulatory Authority regarding matters related to the Genentech Compound, to the extent permitted by such Regulatory Authority.
The Parties shall discuss the additional quantities of the Genentech Compound needed and the schedule on which Genentech shall supply such additional quantities.
If Syndax receives any comments or other inquiries from a Regulatory Authority regarding the Study that pertain specifically to the Genentech Compound, Syndax shall provide such inquiries to Genentech, and Genentech shall provide its responses to Syndax within the timeline imposed by the Regulatory Authority, and in no event later than *** from the date Genentech receives such inquiries from Syndax.
Genentech shall deliver the Genentech Compound to the Delivery Locations in accordance with the Quality Agreement and the timelines specified in the Compound Supply Plan or determined by the Joint Development Committee (or its designees).
Shipments of the Genentech Compound shall include all documentation required by the Quality Agreement.