Master Alliance Provisions Guide (MAPGuide)

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

  • Business model | Product supply

2. Orders

2.1 As of the Effective Date, Customer is deemed to have ordered, and has committed to purchase, and Dynavax is deemed to have accepted such orders and committed to supply, the quantities of Dynavax Adjuvant specified in rows 1 and 2 of the table contained in Annex A of the Supply Agreement. On or within five (5) Business Days after the Effective Date, Customer shall submit Order Form(s) to Dynavax evidencing such commitment by Customer, which, upon submission, shall be binding on both Parties. In addition, if Customer submits to Dynavax an Order for any Additional Q1 2022 Dynavax Adjuvant offered by Dynavax as described in Annex A o f the Supply Agreement prior to expiration of the First Offer Period, such Order, upon submission, will be binding on both Parties.

2.2 In addition to the Orders described in Section 2.1, Customer may issue to Dynavax from time to time during the Term one or more purchase orders (each an “Order” or “Order Form”) for additional Dynavax Adjuvant during the Term, subject to Annex A, provided that an Order Form for Dynavax Adjuvant shall be submitted to Dynavax in accordance with the timing given in Annex A, and, except to the extent set forth in Section 2.3 below, Dynavax may, [***]. If and to the extent Dynavax believes it will be able to supply the quantity set forth in any such Order Form, Dynavax shall provide written confirmation of acceptance of such Order Form, including the quantity (if less than the full quantity) of Dynavax Adjuvant believes it will be able to supply, within five (5) Business Days after its receipt thereof. However, if Dynavax in good faith believes that it will not be able to supply the full quantity of Dynavax Adjuvant specified in an Order Form, then Dynavax shall notify Customer within such five-Business Day period, indicating the quantity of such Dynavax Adjuvant, if any, that Dynavax in good faith believes it will be able to supply by the specified delivery date.

2.3 For clarity, [***]. However, in the event that [***], Dynavax [***], Dynavax shall [***]. 

2.4 Any Orders for Dynavax Adjuvant submitted by Customer shall reference the Supply Agreement and shall be governed exclusively by the terms contained herein. Unless mutually agreed to by the Parties in writing, any term or condition in any Order Form, purchase order, confirmation, or other document furnished by Customer or Dynavax that is in any way inconsistent with, or in addition to, the terms and conditions set forth in the Supply Agreement is hereby expressly rejected.

3. Supply of Dynavax Adjuvant

3.1 Pursuant to the terms and conditions of the Supply Agreement, during the Term (except as provided in Section 15.3), (a) Dynavax (either itself or through the Dynavax CMO) shall manufacture or have manufactured, and supply or have supplied to Customer, the Dynavax Adjuvant in (i) the quantities specified in rows 1 and 2 of the table contained in Annex A of the Supply Agreement, (ii) the quantity (if any) of Additional Q1 2022 Dynavax Adjuvant offered by Dynavax as described in Annex A of the Supply Agreement with respect to which Customer submits an Order prior to expiration of the First Offer Period, (iii) the quantities (if any) set forth in any written confirmation of Order delivered by Dynavax to Customer in response to an Orders submitted by Customer pursuant to Section 2.2, and (iv) the quantities (if any) set forth in any Order submitted by Customer in accordance with Section 2.3 (clauses (i) through (iv), collectively, “Binding Quantities”), and(b) Customer shall purchase from Dynavax all of such quantities of Dynavax Adjuvant. Customer shall inform Dynavax in writing, the identity of the antigen contained in each Customer Vaccine that Customer uses in combination with Dynavax Adjuvant for the development, manufacturing or commercialization of any Customer Product.

3.2 Except to the extent otherwise expressly permitted by Section 4.9 in the event of [***], during the Term and subject to [***], Customer (a) [***], (b) [***], and (c) [***]. For clarity, [***]. 

3.3 In the event that, during or after the Term, Customer or any of its affiliates [***], including, but not limited to,[***], Dynavax shall have the right [***]: (a) [***]; (b) [***]; (c) [***]; (d) [***]; and (e) [***]; provided, however, that, notwithstanding any exercise by Dynavax of its rights set forth above in this Section 3.3, [***] subject to the terms and conditions of the Supply Agreement, and, [***], (i) [***], and (ii) [***]. For the avoidance of doubt, nothing in this Supply Agreement shall [***].

3.4 Dynavax and CEPI have entered into an agreement (the “CEPI Agreement”) whereby CEPI has advanced loans to Dynavax to cover the costs of at-risk manufacture of certain quantities of Dynavax Adjuvant in 2021 (“CEPI Reserved Material”), and Dynavax has agreed to reserve the CEPI Reserved Material for purchase by CEPI partners in such proportions as CEPI may direct. By written notice to Dynavax, CEPI may direct the specified quantities of CEPI Reserved Material be sent to destinations of CEPI’s choice, and Customer hereby consents to Dynavax providing such to Customer such quantities of CEPI Reserved Material as CEPI may direct. The quantities of CEPI Reserved Material supplied to Customer in response to any such direction by CEPI shall be considered as Dynavax Adjuvant supplied as part of an applicable Order placed by Customer.

3.5 Customer and Dynavax shall enter into a Quality Agreement and Pharmacovigilance Agreement, each in a form reasonable and typical for the industry, within thirty (30) days of the Effective Date. The Quality Agreement shall include provisions covering inter alia recalls of Customer Product(s), and Dynavax Adjuvant and the respective responsibilities of the Parties.

4. Delivery of Dynavax Adjuvant

4.1 Dynavax shall ensure that: 

(a) the Dynavax Adjuvant is properly packed and secured in a manner reasonably determined byDynavax to be appropriate for shipping; 

(b) each delivery of the Dynavax Adjuvant is accompanied by a COA, COC as well as a delivery note which shows the date of the Order, the Order number (if any), the type and quantity of the Dynavax Adjuvant (including the code number of the Dynavax Adjuvant (where applicable)), manufacturing date, special storage instructions (if any) and, if the Dynavax Adjuvant are being delivered by instalments, the outstanding balance of Dynavax Adjuvant remaining to be delivered; and 

(c)  it states clearly on the delivery note any requirement for the Customer to return any packaging material for the Dynavax Adjuvant to Dynavax. Any such packaging material shall only be returned to Dynavax at the cost of Dynavax.

4.2 Dynavax shall deliver the Dynavax Adjuvant within five (5) Business Days of the delivery date specified in theOrder and to the location set out in the Order or as otherwise agreed by the Parties before delivery (“Delivery Location”). Dynavax shall not be responsible for any delay in delivery of Dynavax Adjuvant to the extent caused by a third party carrier.

4.3 Dynavax shall deliver all Dynavax Adjuvant [***], and title and risk of loss shall pass from Dynavax toCustomer upon [***]. Customer shall be responsible for [***]. Dynavax shall be responsible for [***]. At Customer’s request, Dynavax shall [***]. 

4.4 Dynavax shall not deliver the Dynavax Adjuvant in instalments without the Customer’s prior written consent. Where it is agreed that the Dynavax Adjuvant can be delivered in instalments, they may be invoiced and paid for separately.

4.5 Customer shall notify Dynavax in writing of any shortage in any shipment of Dynavax Adjuvant within thirty(30) days after receipt. [***]. In the event of an undisputed shortage claim, Dynavax shall make up the shortage of Dynavax Adjuvant at no cost to Customer, and deliver the same within thirty (30) Business Days of receiving such written notification from Customer if replacement Dynavax Adjuvant stock is available, or if replacement stock is unavailable at such time, as soon as reasonably practicable after it becomes available[***].

4.6 Customer shall inspect all shipments of Dynavax Adjuvant promptly upon receipt, and shall notify Dynavax in writing in reasonable detail within thirty (30) days of receipt if Customer is rejecting any Dynavax Adjuvant for any Defect discovered in the course of such inspection. All Dynavax Adjuvant not rejected within such thirty (30)-day period will be deemed accepted. Customer acknowledges that [***] and hereby agrees that [***] Customer shall [***]. Dynavax shall [***]. [***]. Should Dynavax [***], Dynavax shall [***], the Parties shall[***], provided that [***].

4.7 If Customer notifies Dynavax of any Defect in any Dynavax Adjuvant in accordance with Section 4.6, Dynavax shall have the right to inspect the Dynavax Adjuvant in question and Customer shall cooperate with Dynavax’s inspection, including providing Dynavax with samples of the Dynavax Adjuvant in question for testing upon request. If Dynavax agrees with such notice of Defect and agrees that such Defect was caused by occurrences prior to the delivery of the Dynavax Adjuvant to Customer in accordance with Section 4.3, Dynavax shall, at [***] option, either:

(A) replace (at no additional expense to Customer) such Dynavax Adjuvant as soon as reasonably practicable and in any event within one hundred and eighty (180) days after receipt of notification of such Defect or 

(B) refund any portion of the applicable amount that has already been paid for such Dynavax Adjuvant. If necessary to produce replacement Dynavax Adjuvant for Dynavax Adjuvant properly and timely rejected in accordance with Section 4.6, Dynavax shall start another manufacturing run within three (3) months of notice of the Defect and shall deliver the new Dynavax Adjuvant to Customer within six (6) months of the notice of the Defect at no additional cost to the Customer.

4.8 In the event that Dynavax disagrees with Customer that the relevant Dynavax Adjuvant have a Defect, or believes in good faith that the Defect was caused by occurrences after the delivery of the Dynavax Adjuvant to Customer, it may require a sample of the allegedly nonconforming Dynavax Adjuvant to be delivered to a mutually acceptable independent testing laboratory for testing or, in the case of a dispute concerning compliance with cGMP, an independent consultant for evaluation. Except in the case of manifest error, the determination of the laboratory or consultant, as applicable, will be final and binding on the Parties. The fees and expenses of such laboratory testing or consultant, as the case may be, shall be borne entirely by theParty against whom such laboratory’s or consultant’s determination is made. If such determination is againstCustomer, then such Dynavax Adjuvant shall be deemed accepted by Customer. If such determination is against Dynavax, then Dynavax shall, at [***] option, either:

(A) replace (at no additional expense to Customer) such Dynavax Adjuvant as soon as reasonably practicable [***] or

(B) refund any portion of the applicable amount that has already been paid for such Dynavax Adjuvant. If necessary to produce replacement Dynavax Adjuvant, Dynavax shall start another manufacturing run within three (3) months of such determination and shall deliver the new Dynavax Adjuvant to Customer within six (6) months of such determination at no additional cost to the Customer.

4.9 In the event that Dynavax has manufacturing and supply problems rendering it unable to supply during any Quarter the aggregate of the quantity of Dynavax Adjuvant ordered by Customer for delivery in such Quarter and the quantity of Dynavax Adjuvant ordered by Dynavax and third party purchasers for delivery in such Quarter, Dynavax shall promptly notify Customer in writing and allocate the available Dynavax Adjuvant among Customer, Dynavax and its affiliates, and third party purchasers pro rata on the basis of the volume of Dynavax Adjuvant ordered for delivery to Customer in that Quarter and the Dynavax Adjuvant volume requirements of Dynavax, its affiliates and third party purchasers for such Quarter. The allocation rules set forth in this Section 4.9 shall restart for each Quarter, with no carryover from any prior Quarter. In the event that Dynavax [***], then [***], in which event [***]. For clarity, [***]. In the event of [***]: 

(a) [***];

(b) [***]; and 

(c) [***].

4.10 Notwithstanding anything to the contrary in the Supply Agreement, the remedies set forth in Sections 4.5, 4.6,4.7, 4.8 and 4.9 will be Customer’s sole and exclusive remedy and recourse with respect to shortages of and defects in Dynavax Adjuvant delivered to Customer by Dynavax hereunder. Sections 4.5, 4.6, 4.7, 4.8 and 4.9shall apply to any replacement Dynavax Adjuvant supplied by Dynavax.

4.11 Customer shall bear the risk of damage to the Dynavax Adjuvant after delivery to Customer pursuant to Section 4.3. If the Dynavax Adjuvant are damaged after delivery to Customer and Customer intends to order replacement Dynavax Adjuvant, Customer shall promptly notify Dynavax of the damage and any orders for replacement Dynavax Adjuvant, and Dynavax may, at its sole discretion but in good faith, accept or reject all or a portion of the order for the replacement Dynavax Adjuvant.

Annex A: Scope and Pricing Schedule

[…]

[Redacted order schedule table]

The Parties acknowledge that [***]. Should any additional quantity of Dynavax Adjuvant become available for delivery in Q1 2022, Dynavax shall offer such additional Dynavax Adjuvant, up to a maximum of an additional [***] Doses [***] of Dynavax Adjuvant (the “Additional Q1 2022 Dynavax Adjuvant”), to Customer by written notice, stating the available quantity of Additional Q1 2022 Dynavax Adjuvant, and Customer shall have [***] Business Days from delivery of such notice (the “First Offer Period”) in which to submit an Order for such Additional Q1 2022 Dynavax Adjuvant (or a portion thereof) as described in Section 2.1 of Annex B of the Supply Agreement. 

Notwithstanding the table above, the timing for ordering and manufacturing and the timing for delivery for Q3 and Q4 of 2021 may be delayed, and the quantities for Q3 and Q4 of 2021 may be modified, by CEPI in its sole discretion.

Rows 1 and 2 of the table above constitute a binding commitment on the part of Customer to order the applicable quantities set forth in the table above, except to the extent that any such quantities are modified by CEPI.