Master Alliance Provisions Guide (MAPGuide)

Biological E – Dynavax Technologies, COVID-19 Vaccine Adjuvant Supply Agreement

  • Business model | Regulatory strategy

3. Supply of Dynavax Adjuvant

3.10 Dynavax shall ensure that at all relevant and required times it has and maintains (and Dynavax CMO has and maintains) all the licences, permissions, authorisations, consents and permits that it needs to carry out its obligations under the Supply Agreement in respect of the Dynavax Adjuvant. Dynavax will provide (or have provided) to Customer, Dynavax Manufacturing Information and any other information relating to the Dynavax Adjuvant that Customer, any of its affiliates, their Licensees, third party contract manufacturers of Customer Product(s) acting on their behalf, or any Authorized Third Party may reasonably require for purposes of (i) applying for, obtaining and maintaining clinical trial authorisations and Regulatory Approvals for CustomerProduct(s), or (ii) exercising their rights under the Supply Agreement provided that any such information provided by Dynavax shall not be used by or on behalf of Customer, any of its affiliates or their Licensees or any Authorized Third Party for any purpose, other than as expressly permitted hereby or as otherwise required by Applicable Law, in each case, in relation to Customer Product(s). However, for the avoidance of doubt, Customer, its affiliates or their Licensees or Authorized Third Parties, as applicable, shall own and be solely responsible for obtaining and maintaining all licenses, permissions, authorisations, consents, permits and Regulatory Approvals necessary for the research, development, manufacture (excluding manufacture of the Dynavax Adjuvant), use, marketing, promotion, distribution, handling, storage, sale, import, export or other disposition of Customer Vaccine and Customer Product(s), and for complying with all Applicable Laws in connection with carrying out the foregoing activities. 

6. Prices, Royalties and Payments

6.9 Audits

(c) Dynavax shall, where permitted and as soon as reasonably practicable, notify the Customer if it (or the Dynavax CMO) receives notification from any Regulatory Authority or any other authority of an inspection which specifically relates to or impacts on the manufacturing or supply of the Dynavax Adjuvant under the Supply Agreement and will promptly provide to the Customer extracts or copies of all correspondence, reports, notices, findings and other material pertinent to such inspections received or produced by Dynavax, but only if such inspection relates to or impacts the manufacturing and/or supply of the Dynavax Adjuvant under the Supply Agreement (and the scope of such disclosure does not include the aforementioned information to the extent it specifically relates to services provided to other Dynavax clients). Furthermore, Dynavax shall keep Customer reasonably informed of any follow-on actions / remedial measures that may be required to be undertaken by Dynavax/Dynavax CMO to address any issues identified on account of the foregoing. Dynavax shall (and shall cause Dynavax CMO to) diligently attend to any such follow-on actions / remedial measures to ensure that the supply of the Dynavax Adjuvant under the Supply Agreement and the manufacturing and sale of the Customer Product(s) remain unaffected or minimally affected.

10. Confidentiality

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10.4 Specifically and without limiting the foregoing, but subject to Sections 3.3 and 3.10, Dynavax hereby gives consent for Customer, its affiliates, their Licensees, and Authorized Third Party(ies), to disclose Dynavax Confidential Information to Regulatory Authorities solely to the extent necessary to apply for, obtain, update and maintain Regulatory Approval(s) for Customer Product(s). 

10.5 It is understood that in the event that Customer does not have an affiliate in a particular country (or countries),Customer or its affiliate in another country may contract with a third party for that third party to apply for, obtain, update and maintain Regulatory Approval(s) for Customer Product(s) in that country (or countries) on behalf of Customer and/or its affiliate or on such third party’s own behalf if such third party is also a Licensee (any such third party, an “Authorized Third Party”).

10.6 Dynavax shall keep Customer informed of all matters relating to the manufacturing and supply of the Dynavax Adjuvant by or on behalf of Dynavax that would reasonably be expected to require an amendment to, or have an adverse impact, on the Regulatory Approval(s) / regulatory submissions for the Customer Product(s) [***].

12. Compliance with Applicable Laws

12.3 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 or Dynavax CMO manufacturing site, as applicable, and all relevant records necessary or reasonably desirable, in each case, in support of the use of the Dynavax Adjuvant as expressly permitted by the Supply Agreement and shall share the results of such inspection promptly with Customer, in writing.

12.4 If any Regulatory Authority notifies Dynavax CMO or Dynavax of a violation or deficiency in compliance which would impact the use of the Dynavax Adjuvant as expressly permitted by the Supply Agreement, Dynavax shall share such notification with Customer within three (3) days of receipt of the same. [***].