“Quality Agreement” shall mean the quality agreement between Dynavax and the Dynavax CMO setting out the respective responsibilities of Dynavax and the Dynavax CMO in relation to quality as required for compliance with GMP.
2. Manufacture and Reservation of Dynavax Material
2.2 Manufacturing Standards. CEPI acknowledges that all Reserved Product will be manufactured on Dynavax’s behalf by the Dynavax CMO. Dynavax shall comply, and shall be responsible for ensuring that the Dynavax CMO complies, with all Applicable Laws, including GMP, in carrying out Dynavax’s obligations under this Agreement and shall ensure that all necessary approvals are obtained and maintained for the manufacturing facility where the Reserved Materials are manufactured.
4. Compliance and Regulatory
4.4 Regulatory. In addition to the other Compliance Requirements:
(a) Dynavax shall manufacture, sample, test and store all Reserved Material in accordance with the Quality Agreement.
(b) On reasonable prior notice, Dynavax shall provide all reasonable co-operation to any inspection by any regulatory authority and shall permit such regulatory authority access to the Dynavax CMO manufacturing site and all relevant records necessary or reasonably desirable in support of the use of the Reserved Material by CEPI Partners as contemplated by this Agreement.
(c) If any regulatory authority notifies the Dynavax CMO or Dynavax of a violation or deficiency in compliance which would impact the use of the Reserved Material by CEPI Partners as contemplated by this Agreement, Dynavax shall share such notification with CEPI within three (3) days of receipt of the same.