CEPI – Dynavax, COVID-19 Material Reservation Agreement

Equitable Access | Affordable pricing
Equitable Access | Territory access commitments

Structural Questions

Affordable Pricing

How is an ‘affordable price’ determined?
Should there be a difference between the pricing for public sector and private sector purchasers?
Should prices be tiered by country or region and over what time period?
Does the funder have the right to audit the developer’s calculation of ‘affordable price’?
What are the remedies if an ‘affordable price’ is not achieved?

Territory Access Commitments

How should ‘territory’ be defined under the agreement? Should the definition make a distinction between different types of purchaser (e.g. public sector vs. private sector)?
Should the developer be required to apply for regulatory approval in priority access markets?
Should the developer be required to commit a proportion of the product manufactured to a certain country or purchasing organization?
Should the developer be required to identify a third party that could fulfill supply requirements for the access territories in the event that the developer does not?
Should the agreement include any non-diversion provisions?

Summary of Approaches

Affordable Pricing

Should prices be tiered by country or region and over what time period?
- Dynavax must sell the adjuvant to existing CEPI partners in accordance with a specified pricing structure. The full pricing terms are redacted, but different prices are set depending on whether the CEPI Partner Product is for sale to low or high income countries, as well as the dose volume ordered.
- Sales to parties other than existing CEPI partners is subject to redacted terms, although if Dynavax already has a commercial supply agreement with such a party then supply will be in accordance with the pricing terms of that agreement.

Territory Access Commitments

Should the developer be required to commit a proportion of the product manufactured to a certain country or purchasing organization?
- Dynavax is required to supply the Reserved Materials to CEPI Partners at CEPI’s direction.
- If there are no outstanding firm orders or binding commitments for a batch of the material within 90 days of the release date, then Dynavax has the right to sell to other third parties. Dynavax may also request written consent from CEPI to sell to other parties.

Annotations

This is an agreement between Coalition for Epidemic Preparedness Innovations (“CEPI”) and Dynavax for the manufacturing of Dynavax’s proprietary toll-like receptor 9 (TLR) agonist adjuvant known as CpG 1018 (“Dynavax Material” or “Dynavax Adjuvant”). The purpose of the agreement is to further CEPI’s mission in accelerating the development and manufacturing of vaccines against COVID-19. CEPI has advanced an interest-free, forgivable, unsecured loan for specified (but redacted) initial (“Initial Reserved Material”) and optional additional quantities (“Additional Reserved Material” and “Extra Reserved Material”) of the adjuvant.

The Loan Amount is redacted in the agreement, but this CEPI press release states that the initial amount was for USD $99 million and that the agreement was subsequently expanded for an additional USD $77 million.

The terms of the agreement require Dynavax to manufacture the specified quantities, as well as notify CEPI in the event they have extra manufacturing capacity. Under the agreement, CEPI does not take ownership of the Reserved Materials, but is reserving the adjuvant for purchase by parties that have COVID-19 vaccine development or manufacturing funding agreements with CEPI (“CEPI Partners”). The impact of the at-risk investment made by CEPI to reserve materials under this agreement can be seen in a subsequent supply agreement between Dynavax and Biological E, a CEPI Partner receiving funding for its Corbevax vaccine which received emergency use approval in India in December 2021.

Provision Language

Definitions

“Permitted Purchaser” shall mean a CEPI Partner or Permitted Third Party Purchaser that, in each case, purchases Reserved Material.

2. Manufacture and Reservation of Dynavax Material

[…]

2.3 Reservation of Dynavax Material for CEPI Partners. Subject to Section 2.5, Dynavax shall reserve all Reserved Material for purchase by CEPI Partners for use in CEPI Partner Products and shall use it for CEPI Partners in such proportions as CEPI may direct in advance in writing. CEPI may, in its sole discretion, notify Dynavax in writing of one or more COVAX Approved Partners that CEPI desires to designate as “CEPI Partners” under this Agreement at any time. Unless Dynavax notifies CEPI within 15 Business Days of receipt of any such notice with respect to a COVAX Approved Partner that Dynavax is unwilling to supply Dynavax Material to such COVAX Approved Partner for legitimate business reasons (which notice shall set forth the basis for Dynavax’s unwillingness), such COVAX Approved Partner shall be deemed a “CEPI Partner” for purposes of this Agreement upon the expiration of such 15–Business Day period. If CEPI wishes to have Dynavax sell and supply Reserved Material to a particular CEPI Partner, CEPI shall deliver written notice to Dynavax of each CEPI Partner to which CEPI wishes to have Dynavax sell and supply Reserved Material, and shall instruct such CEPI Partner to contact Dynavax at [***].

2.4 Disposition of Reserved Material. Dynavax shall use commercially reasonable efforts to sell all of the Reserved Material to Permitted Purchasers in accordance with this Section 2.4 and Sections 2.3 and 2.5. Should a CEPI Partner referred to Dynavax by CEPI pursuant to Section 2.3 contact Dynavax regarding the purchase of Reserved Material for use in CEPI Partner Products, Dynavax shall negotiate in good faith directly with such CEPI Partner a supply agreement on commercially reasonable and customary terms mutually acceptable to Dynavax and such CEPI Partner; provided, however, that:

(a) the purchase price(s) per dose of Reserved Material supplied to the existing CEPI Partners identified in Exhibit B hereto (“Existing CEPI Partners”) shall be as specified in Exhibit B;

(b) subject to Section 2.4(c), the purchase price(s) per dose of Reserved Material supplied to any CEPI Partner other than an Existing CEPI Partner shall be determined as follows:

(i) [***]; and

(ii) [***];

(c) notwithstanding Section 2.4(b), in the case of any CEPI Partner (other than an Existing CEPI Partner) with which Dynavax has an effective commercial supply agreement for the Dynavax Adjuvant for such CEPI Partner’s CEPI Partner Product as of the date when CEPI delivers written notice to Dynavax that CEPI wishes to have Dynavax sell and supply Reserved Material to such CEPI Partner, the purchase price(s) per dose (regardless of dose size) of Reserved Material supplied to such CEPI Partner shall be the purchase price(s) per dose specified in such commercial supply agreement; and

(d) in each such supply agreement the obligation on Dynavax to ship and supply, as it relates to the Reserved Material, shall be contingent upon CEPI’s direction that such portion of the Reserved Material be supplied to such customer.

2.5 Supply of Reserved Material to Permitted Third Party Purchasers. At any time when there are no outstanding firm orders or binding commitments from CEPI Partners for Reserved Material and no supply agreement is then under negotiation between Dynavax and any CEPI Partner, Dynavax may request in writing (which request may be delivered by email to both of CEPI’s nominated contacts specified in Section 13.8) CEPI’s consent, which shall not be unreasonably withheld, to the sale and supply by Dynavax to third party(ies) other than CEPI Partners of available Reserved Material. If CEPI fails to respond to any such request for consent within five (5) Business Days of Dynavax’s request (which response may be delivered by email to Dynavax’s nominated contact specified in Section 13.8), then CEPI shall be deemed to have consented to Dynavax’s sale and supply of Reserved Material to such third party(ies). In addition, if any batch of Reserved Material is not subject to firm orders or binding commitments from CEPI Partners for Reserved Material and no supply agreement for Reserved Material is then under negotiation between Dynavax and any CEPI Partner within 90 days after the Release Date for such batch, Dynavax shall have the right to sell such batch of Reserved Material to third parties. Any such permitted sale and supply to a third party other than a CEPI Partner (such third party, a “Permitted Third Party Purchaser”) shall be on terms, including purchase price, to be determined by Dynavax in its sole discretion.

Exhibit B: Pricing for Existing CEPI Partners

Existing CEPI Partner

Size of Dose of Dynavax AdjuvantPricing (in United States Dollars)

[***][***] milligrams, net of any overage

LMIC Price. For Reserved Material for use in CEPI Partner Product for sale or distribution in countries supported by the Advance Market Commitment of the COVAX Facility as listed at the following website:

https://www.gavi.org/news/media–room/92–low–middle–income–economies–eligible–access–covid–19–vaccines–gavi–covax–amc

(“LMICs”):

USD [***] per dose of Reserved Material for total combined calendar year orders of Reserved Material between [***] and [***] doses
USD [***] per dose of Reserved Material for total combined calendar year orders of Reserved Material between [***] and [***] doses
USD [***] per dose per dose of Reserved Material if total combined calendar year orders of Reserved Material exceed [***] doses

HIC Price. For Reserved Material for use in CEPI Partner Product for sale or distribution in countries that are not LMICs (“HICs”):

USD [***] per dose of Reserved Material

For clarity, the pricing set forth above applies solely to Reserved Material supplied and sold to [***]. The pricing of any Dynavax Material, other than Reserved Material, supplied and sold by Dynavax to [***] shall be mutually agreed by Dynavax and [***] without regard to this Agreement.

[***][***] milligrams, including overage

LMIC Price. For Reserved Material for use in CEPI PartnerProduct for sale or distribution in LMICs:

USD [***] per dose of Reserved Material

HIC Price. For Reserved Material for use in CEPI Partner Product for sale or distribution in HICs:

USD [***] per dose of Reserved Material

Master Alliance Provisions Guide (MAPGuide)

CEPI – Dynavax, COVID-19 Material Reservation Agreement

Provision Language

Contact Us

Get In Touch

Browse

Contact Us

Get In Touch

Browse

Sign Up to Our Newsletter

Master Alliance Provisions Guide (MAPGuide)

CEPI – Dynavax, COVID-19 Material Reservation Agreement

Provision Language

Contact Us

Get In Touch

Browse

Contact Us

Get In Touch

Browse

Title

Sign Up to Our Newsletter

Agreement Type

Select Partner Type

Select Development Stage

Select Technology

Select Issue or Sub-issues