Examples of Dynavax CMO in a sentence
Dynavax shall remain responsible for all the acts and omissions of the Dynavax CMO and any of its other subcontractors as if they were its own.
The Request for Information was also sent to thirteen other PRPs. On July 14, 2005, the Company received a General Notice Letter from EPA notifying the Company that EPA believes the Company may be liable under CERCLA and requesting the Company, along with other PRPs, voluntarily perform clean-up activities at the site.
Dynavax shall obtain similar written assurances from the Dynavax CMO that neither the Dynavax CMO, nor any officer or employee of the Dynavax CMO, has been debarred or is subject to debarment by any regulatory authority.
Subject to the terms and conditions of this Agreement, and in consideration for CEPI advancing the Extra Loan Amount in accordance with Section 3.1(b), Dynavax will use commercially reasonable efforts to reserve extra manufacturing capacity at the Dynavax CMO to manufacture and release up to a further [***]kg of Dynavax Material in 2021.
For the avoidance of doubt, Dynavax will not be obligated to submit to the Dynavax CMO an order for Dynavax Adjuvant ordered by Customer for delivery in 2022 prior to Dynavax’s receipt from Customer of payment of the initial [***] percent ([***]%) of the aggregate price of such Dynavax Adjuvant invoiced under this Section 6.2(b).
If Dynavax changes the approved Dynavax CMO that necessitates the vendor / product qualification for the use of Dynavax Adjuvant hereunder, Dynavax shall provide samples of Dynavax Adjuvant in quantities reasonably required for such purpose to Customer at no additional cost to Customer.
If Dynavax identifies Extra Capacity, Dynavax shall promptly notify CEPI thereof, which notice shall specify the number of kilograms of Dynavax Material that the Dynavax CMO will be able to manufacture using such Extra Capacity, the anticipated timing of manufacture and release and the manufacturing cost per kilogram of such Dynavax Material (such notice, the “Extra Capacity Notice”).
If Dynavax proposes to subcontract any of its material obligations under the Supply Agreement, other than subcontracting of the manufacture of Dynavax Adjuvant to be supplied under the Supply Agreement to the Dynavax CMO, Dynavax shall (i) provide prior written notice to Customer of such subcontracting and identity of the subcontractor; and (ii) ensure that any such subcontract is consistent with the terms and conditions of the Supply Agreement.
For clarity, under no circumstances shall Dynavax have any obligation to pay or repay to CEPI any portion of the Loan Amount advanced to Dynavax that Dynavax has paid or is obligated to pay to the Dynavax CMO and has no contractual right to recover and does not actually recover from the Dynavax CMO.
Dynavax acknowledges a continuing obligation to promptly disclose to CEPI if Dynavax is not in compliance with the foregoing Representations and Warranties or if the Dynavax CMO cannot give similar assurances.