Master Alliance Provisions Guide (MAPGuide)

CEPI – Dynavax, COVID-19 Material Reservation Agreement

  • Business model | Regulatory strategy

<p class=”p1“>“<b>Quality Agreementb>” shall mean the quality agreement between Dynavax and the Dynavax <a href=”#kt“>CMOa> setting out the respective responsibilities of Dynavax and the Dynavax CMO in relation to quality as required for compliance with <a href=”#kt“>GMPa>.p>
<p><span style=”textdecoration: underline;”><strong>2. Manufacture and Reservation of Dynavax Materialstrong>span>p>
<p><strong>2.2 Manufacturing Standards.strong> CEPI acknowledges that all Reserved Product will be manufactured on Dynavaxs 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 Dynavaxs 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.p>
<p><span style=”textdecoration: underline;”><strong>4. Compliance and Regulatorystrong>span>p>
<p><b>4.4 Regulatory. b><span style=”fontweight: 400;”>In addition to the other Compliance Requirements:span>p>
<p>(a) <span style=”fontweight: 400;”>Dynavax shall manufacture, sample, test and store all Reserved Material in accordance with the Quality Agreement.span>p>
<p>(b) <span style=”fontweight: 400;”>On reasonable prior notice, Dynavax shall provide all reasonable cooperation 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.span>p>
<p>(c) <span style=”fontweight: 400;”>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.span>p>