“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.
“Novavax Doses” means three hundred and fifty (350) million doses of CFN Vaccine as adjusted pursuant to Clause 2.2 (as applicable).
“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.
“Stop Criterion” means the occurrence of an adverse safety signal in any population in which the Vaccine is being or has been tested that a Party, in good faith and in accordance with such Party’s medical safety evaluation, believes gives rise to a material risk that the safety profile of Vaccine is not suitable for Regulatory Approval.
(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.
4. Novavax Supply
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.
5.3 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.
14. Disputes, Arbitration, Expert Determination
14.1 Subject to Clause 14.2, all disputes arising out of or in connection with this Agreement, including disputes as to its conclusion, validity, existence, binding effect, amendment and termination, including a dispute as to the validity and existence of this Clause 14.1, which cannot be resolved by the CEOs of the Parties within [***] after notice of such dispute is first given by a Party to the other Party, shall be resolved by arbitration, in accordance with the [***] (the [***]) (the [***]). The number of arbitrators shall be [***], [***] appointed by or on behalf of each Party and the [***] arbitrator, who shall act as president of the tribunal, shall be appointed by the [***] arbitrators appointed by or on behalf of the Parties. If the [***] arbitrator is not chosen and nominated to the [***] for appointment within [***] of the date of confirmation of the later of the [***] party-appointed arbitrators to be confirmed by the [***], he/she shall be chosen by the [***]. No arbitrator shall be of the same nationality as any Party. The tribunal shall draw up, and submit to the Parties for signature, the terms of reference within [***] of receiving the file. The terms of reference shall not include a list of issues to be determined. The seat (or legal place) shall be in [***]. The language of the arbitration shall be English. The Parties agree to be bound by any award made by the tribunal. The Parties further agree to comply with any orders (including interim orders) in accordance with the terms of such orders. The Parties waive their right to any form of appeal, review or recourse to any state court or other legal authority, insofar as such waiver shall not be prohibited under any applicable law. For the avoidance of doubt, the Parties do not agree to opt out of the [***] (as defined in the [***]). The Parties undertake to fully comply with any order rendered by the emergency arbitrator in accordance with the terms of such order, to the extent that such order is not terminated or annulled by the emergency arbitrator or by the tribunal.
14.2 Where this Agreement refers to a determination by an Expert, the Parties shall, within [***] of either Party serving details of a suggested expert on the other, agree the identity of the Expert and the proposed terms of his or her appointment.
14.2.1 If the Parties are unable to agree the identity and/or terms of his or her appointment within that period, either Party shall be entitled to request the [***] to appoint a suitable Expert and for the [***] to agree with the Expert the terms of his or her appointment.
14.2.2 The Parties shall be entitled to make submissions to the Expert. The Parties shall promptly provide to the Expert (imposing appropriate obligations of confidence with regard to third parties) all information reasonably requested by the Expert relating to the particular dispute.
14.2.3 The Parties shall require the Expert to prepare a written decision and to give notice (including a copy) of the decision to the Parties within a [***] of the matter being referred to the Expert (or such shorter time as the Parties may agree), and the Parties shall provide all reasonable co-operation to the Expert to achieve this objective.
14.2.4 The Expert will act as an Expert and not as an arbitrator and his or her decision will, except in the case of fraud, be final and binding on the Parties. Each Party will bear its own costs, [***]. All matters concerning the process and results of the determination by the Expert shall be kept confidential among the Parties and the Expert and shall be deemed Confidential Information hereunder.