“Backstop Volume” means the NVSN Cumulative Volume less the Novavax Doses.
“CFN” means, for the purposes of this Agreement, the following manufacturing facilities funded in whole or part by CEPI under the CEPI Funding Agreement in which CFN Drug Substance is made: [***].
“CFN Drug Substance” means any drug substance manufactured using the CFN.
“CFN Vaccine” means any Vaccine that contains CFN Drug Substance.
“COVAX Buyer” means any one of such Designated Procurement Agencies or Self-Procuring Countries.
“Delivery Period” means from the date of this Agreement until the end of Q2 of 2022.
“Designated Procurement Agency” means any procurement agency designated by Gavi and notified to Novavax as an agency acting on Gavi’s behalf when procuring COVAX Doses under this Agreement. Designated Procurement Agencies may include UNICEF, PAHO, or any procurement agency as designated by Gavi.
“Early Supply Period” means the period from the date of this Agreement until the last day of the month when each of the following events has occurred:
(a) the Covovax Vaccine receives Emergency Use Listing by the WHO or WHO Prequalification;
(b) the Minimum Level Doses have been delivered to Gavi (or one or more relevant COVAX Buyers) by Novavax pursuant to this Agreement; and
(c) SII has delivered in [***], such period starting no earlier than [***], no less than [***] of the Covovax Scheduled Doses for such month in accordance with the Covovax Schedule.
“Humanitarian Buyer” means any non-governmental organisation (or such other persons [***]) which procures COVAX Doses on behalf of refugees, asylum seekers or other vulnerable populations or missed communities;
“Minimum Level Doses” means [***] ([***]) of the initial [***] ([***]) doses of CFN Vaccine delivered by Novavax.
“Novavax Doses” means three hundred and fifty (350) million doses of CFN Vaccine as adjusted pursuant to Clause 2.2 (as applicable).
“Novavax Routine Supply Period” means the period from the expiry of the Early Supply Period to the expiry of the Term (or Termination, if earlier).
“NVSN Cumulative Volume” means the cumulative volume of one billion and ninety-two million (1,092,000,000) doses of Novavax Doses and Covovax Vaccine to be supplied by Novavax and SII respectively.
“Purchase Condition” means the Vaccine having received one of the following: (i) Regulatory Approval; (ii) Emergency Use Listing by the WHO; or (iii) where reasonably agreed to by Gavi, Emergency Use Authorisation.
“Self-Procuring Countries” means countries which choose to procure Vaccine by entering into a Supply Agreement directly with Novavax.
“SII Procurement Prepayment Agreement” means the agreement for the manufacture and sale of a COVID-19 vaccine entered into between Gavi and SII dated [***] (and as further amended from time to time).
“Vaccine Condition” means the Vaccine being suitable for administration to all persons over the age of 18.
(E) The Parties acknowledge that Novavax and SII (as defined below) have entered into a Supply and License Agreement (“SII License”) under which Novavax has licensed Novavax Intellectual Property Rights (as defined below) to SII and SII will thereafter produce the Vaccine, which SII intends to sell under SII’s brand name ‘Covovax’ (any such vaccine produced by SII under such rights, the “Covovax Vaccine”). Gavi acknowledges that, consistent with equitable access principles and Novavax’s obligations under its agreement with CEPI, Novavax licensed its proprietary technology to SII with no traditional upfront or milestone benefit to Novavax (but with Novavax sharing in some of the revenue made by SII from Covovax Vaccine sales) and further that SII is well-suited to provide primary sale and distribution of the Covovax Vaccine into LICs, LMICs and UMICs, including through the COVAX Facility. (F) The Parties also acknowledge that Gavi has entered into the SII Procurement Prepayment Agreement (as defined below) which provides for purchase of Covovax Vaccines manufactured by SII (or its Affiliates) at a maximum price of $[***] per dose to be supplied to certain eligible countries. The Parties further acknowledge that an additional agreement is under discussion between Gavi and SII in relation to the procurement of additional doses of Covovax Vaccines (the “Covovax APA”). The Parties acknowledge that the total volume of Novavax Doses (as defined below) and Covovax Vaccine (to be provided pursuant to the SII Procurement Prepayment Agreement and the Covovax APA) is expected to equal the NVSN Cumulative Volume (as defined below).
(F) The Parties also acknowledge that Gavi has entered into the SII Procurement Prepayment Agreement (as defined below) which provides for purchase of Covovax Vaccines manufactured by SII (or its Affiliates) at a maximum price of $[***] per dose to be supplied to certain eligible countries. The Parties further acknowledge that an additional agreement is under discussion between Gavi and SII in relation to the procurement of additional doses of Covovax Vaccines (the “Covovax APA”). The Parties acknowledge that the total volume of Novavax Doses (as defined below) and Covovax Vaccine (to be provided pursuant to the SII Procurement Prepayment Agreement and the Covovax APA) is expected to equal the NVSN Cumulative Volume (as defined below).
(I) The Parties acknowledge that Gavi will not enter into a supply agreement with Novavax for Vaccine, but rather, Gavi’s role will be limited to providing certainty to Novavax as to the demand for Vaccine and securing doses for the COVAX Participants (as defined below). The Parties further acknowledge that the terms relating to the supply of Vaccine will be agreed between Novavax and such COVAX Participants. Gavi has additionally indicated its willingness to use Commercially Reasonable Endeavours to facilitate the contracting process between Novavax and COVAX Participants and establish processes and conditions regarding terms of supply under the COVAX Facility, which may include streamlined regulatory, packaging, labelling, pharmacovigilance, distribution approaches and contracting timelines.
(J) Considering Gavi’s and Novavax’s desire to secure access to three hundred and fifty (350) million doses of the Vaccine for distribution to COVAX Participants through the mechanism designated by the ACT Accelerator, the Parties wish to enter into this Agreement for the procurement of the Vaccine by COVAX Participants.
2. Gavi Advance Purchase Commitment
2.1 Subject to Clause 2.2 and satisfaction of the Purchase Condition (unless such satisfaction is waived by Gavi in its sole discretion), Gavi agrees to procure the purchase of the Novavax Doses by COVAX Buyers from Novavax for the COVAX Participant Price (the “Firm Order Commitment”).
2.2 In the event that the Vaccine Condition is not satisfied, the Parties acknowledge and agree that Gavi may, in its [***] discretion, reduce the Novavax Doses by such number of doses as it deems appropriate (in Gavi’s [***] opinion) to reflect any reduction in projected demand of the Vaccine. Gavi shall notify Novavax of any such reduction no later than [***] after satisfaction of the Purchase Condition.
4. Novavax Supply
4.1 During the Early Supply Period, Novavax shall deliver at least [***] ([***) (measured [***]) of all CFN Vaccine to the COVAX Buyers, and in accordance with the Interim Delivery Schedule, at the relevant COVAX Participant Price; and in so doing, give first priority to supplying such COVAX Doses (in relation to prioritising delivery timescales, provision of information and other supply terms). During the Early Supply Period, Novavax shall be entitled to deliver up to [***] ([***)) (measured [***]) of all CFN Vaccine to any Novavax Buyer as it sees fit in its sole discretion.
4.2 During the Novavax Routine Supply Period (and subject to Clause 4.3) Novavax shall continue to deliver at least [***] ([***]) (measured [***]) of all CFN Vaccine to the COVAX Buyers, and in accordance with the Interim Delivery Schedule, at the COVAX Participant Price; and in so doing, give first priority to supplying such COVAX Doses (in relation to prioritising delivery timescales, provision of information and other supply terms). During the Novavax Routine Supply Period, Novavax shall be entitled to deliver up to [***] ([***]) (measured [***]) of all CFN Vaccine to any Novavax Buyer as it sees fit in its sole discretion.
4.3 The Parties acknowledge and agree that COVAX Doses delivered pursuant to this Agreement shall be deployed across each of the COVAX Participant Tiers as allocated by Gavi in its sole discretion pursuant to Clause 5. Notwithstanding the previous, Gavi will use Commercially Reasonable Endeavours during the Novavax Routine Supply Period to allocate no more than [***] ([***]) (measured [***) of such COVAX Doses to [***]. The Parties agree that:
4.3.1 Gavi will use Commercially Reasonable Endeavours to notify Novavax of its allocations:
(i) in relation to deliveries which take place during the first [***] of delivery by Novavax, promptly upon receiving the outcome of the allocation pursuant to the Allocation Framework; and
(ii) in relation to all ongoing deliveries, [***] in advance of the initiation of each [***],
(each, a “[***] Notification”). References to “[***]” in this Clause 4.3.1, may not align to a calendar [***] (i.e., a [***] will be a period of [***]).
4.3.2 In the event that the allocations of COVAX Doses to [***] notified to Novavax in a [***] Notification are expected to exceed the [***] (such excess COVAX Doses, the “Additional Discretionary Doses”), Novavax shall be entitled to notify Gavi within [***] of the applicable [***] Notification that it intends to sell a specified quantity of the Additional Discretionary Doses to a Novavax Buyer, in which case such specified quantity of Doses shall not constitute Novavax Doses.
4.3.3 Notwithstanding the [***], any quantity of Additional Discretionary Doses that are not covered by the notification provided by Novavax pursuant to Clause 4.3.2 above may be deployed by Gavi across any of the COVAX Participant Tiers in its sole discretion and if ordered and so deployed shall constitute Novavax Doses.
4.4 Where Gavi or SII notifies Novavax in writing that SII is unable to, or is unlikely to be able to, deliver the volume of Covovax Scheduled Doses set out in the Covovax Schedule by an amount in excess of [***], Novavax shall, at Gavi’s request, notwithstanding the provisions of this Clause 4, use [***] to deliver all doses of CFN Vaccine at the applicable Purchase Price, up to the same amount by which Gavi or SII has notified Novavax that SII is unable to, or unlikely to be able to, supply (such doses the “Backstop Supply”), provided that:
4.4.1 Novavax will not be expected to redirect any CFN Vaccine that has been packed and labelled in a manner which is unsuitable for the COVAX Participants;
4.4.2 Backstop Supply shall not include CFN Vaccine for which notice has been provided to the recipient Novavax Buyer that shipment of such CFN Vaccine has been initiated and such shipment must be delivered at that particular time pursuant to a binding legal obligation; and
4.4.3 Backstop Supply shall not exceed the Backstop Volume.
4.5 Absent action pursuant to the USA Defense Protection Act or equivalent regional laws or regulations applicable to the CFN Vaccine, Novavax shall not attempt to circumvent or take any steps to prejudice the priority of the COVAX Facility.
4.6 Without prejudice to any other provision of this Agreement, if the above is insufficient to deliver the COVAX Doses, Novavax shall use [***] to deliver for the COVAX Facility other doses of Vaccine (not COVAX Doses) aligned to its non-US production capacity and taking into account any Novavax Buyers and business priorities.
4.7 In order to avoid expiration of CFN Vaccine before it can otherwise be delivered and effectively administered, Gavi and Novavax agree to discuss, on a [***] basis (or such other frequency as the Parties may agree), stock and production levels and expiry/shelf-life management of the CFN Vaccine. Provided always that Novavax is meeting its obligations under Clause 7, Gavi and Novavax further agree:
4.7.1 prior to Emergency Use Listing being granted by the WHO, to discuss in good faith appropriate allocation and delivery of any CFN Vaccines with an expiry date/shelf life of [***] or less; and
4.7.2 subsequent to Emergency Use Listing being granted by the WHO:
(i) to discuss in good faith appropriate allocation and delivery of any CFN Vaccines with an expiry date/shelf life of [***] or less; and
(ii) upon reasonable prior written notice to Gavi and in the absence of a contrary Gavi written request received within [***] of Gavi’s receipt of such notice, Novavax shall be permitted to deliver Expiring CFN Vaccine to a Novavax Buyer or other third party.
5. Allocation of COVAX Doses
5.1 Gavi may allocate COVAX Doses to any COVAX Participant. Decisions as to how the COVAX Doses are allocated between COVAX Participants shall be made in accordance with the terms of the COVAX Facility and the Allocation Framework and in accordance with Clause 4.3. Novavax shall deliver Vaccine to each COVAX Buyer pursuant to the relevant Supply Agreement.
5.2 Gavi may, in addition to allocating COVAX Doses to COVAX Participants, allocate COVAX Doses to Humanitarian Buyers. Decisions on how such allocations are made shall be made solely by Gavi, it being understood that supply to any Humanitarian Buyer is subject to Novavax’s consent, such consent [***].
Novavax shall consider requests to supply COVAX Doses to Humanitarian Buyers in good faith, taking into account factors including: [***].
5.3 The Parties shall meet once every [***] (or such other frequency as agreed by the Parties) to review past allocations and expected allocations by Gavi of COVAX Doses to any COVAX Participant.
7. Novavax Commitments
7.1 Regulatory Approval […]
7.1.2 Novavax shall:
(i) use best endeavours to obtain Emergency Use Authorisation and Emergency Use Listing for the Vaccine by no later than [***] after the expected date set out in the Regulatory Submission Plan, and in any event by no later than [***] after submission for WHO assessment through the Emergency Use Listing or WHO Prequalification procedure; and shall ensure WHO submission is no later than the time of submission to the Stringent Regulatory Authority which is appointed to be the National Regulatory Authority of Record; and
(ii) use Commercially Reasonable Endeavours to obtain Regulatory Approval for the Vaccine, by no later than [***] after the expected date set out in the Regulatory Submission Plan.
7.1.3 Novavax shall use Commercially Reasonable Endeavours to obtain such regulatory approvals as are required to enable the Vaccine to be used in each COVAX Participant country where allocated COVAX Doses are intended to be sold pursuant to this Agreement, taking into account cost, complexity of obtaining approval in such COVAX Participant country and the benefit of such regulatory approval.
7.2 Delivery, Variance, Short Supply
7.2.1 Novavax shall make available the COVAX Doses pursuant to the order and supply process set forth in Clause 8 and Novavax shall use its Commercially Reasonable Endeavours to meet the [***] timelines set out in the Interim Delivery Schedule in relation to the Firm Order Commitment. Gavi hereby acknowledges and agrees that [***] the quantity of Vaccine actually delivered to each COVAX Buyer each [***] may vary by plus/minus [***] of the aggregate amount specified in the Supply Agreement of such COVAX Buyer provided such variance is not caused by any Excess Leakage (“Permitted Variance”).
7.2.2 If Novavax reasonably believes that it will not be able to supply a COVAX Buyer with quantities of Vaccine in accordance with this Agreement or the relevant Supply Agreement, taking into account the Permitted Variance, then Novavax shall notify Gavi and the COVAX Buyer in writing of such circumstances [***], including the underlying reasons for such shortage, the date such inability is expected to end and Novavax’s remedial plan to enable the Vaccine to be supplied to such COVAX Buyer in accordance with this Agreement (and the relevant Supply Agreement), which plan must reasonably be expected to resolve such short supply (the “Remedial Plan”). For the avoidance of doubt, the Parties acknowledge and agree that a Permitted Variance and any action to be taken pursuant to a Remedial Plan shall be without prejudice to Novavax’s obligations under Clauses 4.1 and 4.2 (as applicable) to deliver the relevant proportion of CFN Vaccine to COVAX Buyers. Novavax shall in good faith take into account any reasonable changes to the Remedial Plan proposed by Gavi and/or the COVAX Buyer.
7.2.3 If the actions outlined in the Remedial Plan:
(i) resolve the issue causing such failure to supply to a COVAX Buyer within [***] of the exceeded variance giving rise to the Remedial Plan and Novavax delivers the amount of Vaccine contemplated by the delivery schedule in the Supply Agreement during such period, the COVAX Buyer’s purchase obligations shall remain unchanged;
(ii) resolve the issue causing such failure to supply to a COVAX Buyer within [***] of the exceeded variance giving rise to the Remedial Plan, but Novavax does not deliver the amount of Vaccine contemplated by the delivery schedule in the Supply Agreement for such period, the COVAX Buyer may, upon written notice to Novavax, cancel delivery of the COVAX Doses that were scheduled for delivery during the duration of the supply failure that were not delivered; or
(iii) do not resolve the issue causing failure to supply to a COVAX Buyer within [***] of the exceeded variance giving rise to the Remedial Plan, the relevant COVAX Buyer(s) may upon written notice to Novavax cancel delivery of all undelivered Vaccine units (past due deliveries and future deliveries) or terminate the Supply Agreement (or both).
7.2.4 If a COVAX Buyer elects to cancel past due and/or future deliveries of Vaccine and/or terminate the Supply Agreement pursuant to Clause 7.2.3, such COVAX Buyer shall be relieved of its obligation to pay the COVAX Participant Price for such undelivered Vaccine units and Novavax shall be relieved of its obligation to deliver such Vaccine units (the “Cancelled Doses”). For the avoidance of doubt, the Parties acknowledge and agree that Gavi’s obligation to procure the purchase of the Novavax Doses pursuant to this Agreement shall be satisfied notwithstanding any cancellation pursuant to Clause 7.2.3.
7.2.5 The Parties intend that the delivery of Vaccine shall be completed during the Delivery Period. To this end, Novavax shall:
(i) adhere to underlying principles of regulatory harmonisation (in relation to its obligations in Clause 7.1) and streamlined logistics requirements, including packaging, labelling, and post-marketing requirements across the COVAX Participants; and
(ii) inform Gavi and the COVAX Procurement Coordinator immediately, but in no event later than [***], after it becomes aware of any circumstances indicating a material deviation from the timelines outlined in Clause 7.2.1 and/or the Interim Delivery Schedule.
7.2.6 Novavax shall, at [***] cost, deliver the doses ordered by the COVAX Buyer to a central distribution hub specified in the Supply Agreement, from which the Designated Procurement Agency or COVAX Participant will ensure themselves the further delivery to the sites of use of the Vaccine, in accordance with any procedure set out in the relevant Supply Agreement.
8. Order and Supply of COVAX Doses
8.1 Agreements with COVAX Buyers
8.1.1 The Parties agree that the terms and conditions of the order, purchase, supply, delivery and payment process for Vaccine shall be regulated in procurement agreements between Novavax and each COVAX Buyer (each a “Supply Agreement”). Novavax acknowledges that each Self-Financing Participant may choose to either purchase Vaccine directly from Novavax or through a Designated Procurement Agency. The Parties acknowledge that a Supply Agreement may itself constitute a Binding Purchase Order where that constitutes a firm order for COVAX Doses to which the COVAX Buyer and Novavax are contractually bound, or that a further purchase order may need to be placed under the terms of a Supply Agreement to constitute a Binding Purchase Order.
8.1.2 Novavax shall use [***] to enter into a Supply Agreement with each Designated Procurement Agency, and [***] to enter into a Supply Agreement with all other COVAX Buyer(s) as soon as [***] to enable Vaccines to be delivered in accordance with the Interim Delivery Schedule. Novavax shall regularly update Gavi on the progress it has made in concluding Supply Agreements with COVAX Buyers.