Master Alliance Provisions Guide (MAPGuide)

CEPI – Dynavax, COVID-19 Material Reservation Agreement

  • Equitable Access | Access plans & principles

Recitals

Whereas, CEPI’s mission is to accelerate the development of vaccines against emerging infectious diseases and enable equitable access to these vaccines for affected populations during outbreaks;

Whereas, CEPI has entered or may enter in the future into legal agreements with certain third parties (each, a “CEPI Partner”) regarding the funding of development and manufacturing initiatives of vaccines for COVID-19; 

Whereas, to further its mission, CEPI desires to advance an interest-free, forgivable, unsecured loan to cover the costs of at risk manufacture of specified quantities of the CpG 1018 adjuvant and to reserve such quantities for purchase by CEPI Partners for use in development and manufacturing of vaccines against COVID-19; […]

4. Compliance and Regulatory

4.2 CEPI Third Party Code. The CEPI Third Party Code is a statement of CEPI’s values and of the policies, practices and principles applicable to recipients of any funds from CEPI.

(a) Dynavax acknowledges the statement of CEPI’s values in Section 1 of the Code.

(b) Dynavax acknowledges CEPI’s expectation that Dynavax shall adhere to business practices, ethical principles and legal requirements that are at least substantially similar to those described inSections 2 to 10 of the Code.

(c) Dynavax shall comply with the requirements for reporting compliance concerns and misconduct to CEPI (Sections 4 and 11 of the Code).

(d) Dynavax shall cooperate as may be requested by CEPI in the submission of information related to Project activities and expenditures in accordance with the International Aid TransparencyInitiative (Section 12 of the Code).

(e) Dynavax shall comply with CEPI’s Equitable Access Policy.

(f) To the extent applicable to the Project, Dynavax shall comply with CEPI’s Animals inResearch Policy.

(g) To the extent applicable to the Project, Dynavax may rely upon its own substantially similar policies and principles so as to comply with: (i) CEPI’s Clinical Trials Policy; (ii) CEPI’s Managing Conflicts Of Interest Policy; (iii) CEPI’s Scientific Integrity Policy; and (iv) CEPI’s Travel and Expenses Policy.

(h) Dynavax shall comply with the provisions related to Sub-Contracts (Section 14 of theCode) and to Sub-Grants (Section 15 of the Code).

4.3 Amendments to the CEPI Third Party Code. CEPI may amend the Third Party Code and/or the CEPI policies incorporated by reference therein from time to time. CEPI shall give Dynavax at least thirty (30)days’ written advance notice of such amendments taking effect. If in the reasonable opinion of Dynavax any proposed amendment is likely to have a substantial adverse effect on Dynavax and/or the Project, Dynavax shall promptly notify CEPI. On receipt of such notice, the Parties will discuss and seek to agree in good faith about how to proceed.