Provision Language
Definitions
“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.
“Solvency–Related Event” means any action, legal proceeding or other procedure or step that is taken in relation to any of the following events or any of the following events occurring with respect to one Party: (i) a suspension of payments, a moratorium of any indebtedness, winding–up, dissolution, termination of existence, insolvent liquidation, administration, reorganization (by way of voluntary arrangement, scheme of arrangement or otherwise), bankruptcy, insolvency, judicial management or curatorship; (ii)a settlement, deferred payment, debt restructuring, transfer, restructuring, composition, compromise, assignment or similar arrangement of the relevant Party with any of its creditors; (iii) the appointment of a liquidator, trustee, receiver, administrative receiver, administrator, compulsory manager or other similar officer in respect of the relevant Party or any of its assets; or (iv) any analogous procedure or step that is taken by any governmental authority (excluding any bona fide procedure relating to a solvent liquidation, merger or transformation).
“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.
“Supply Failure” means the occurrence of any of the following:
(a) Novavax fails to deliver Vaccine to a COVAX Buyer in accordance with the terms of the relevant Supply Agreement;
(b) Novavax stops accepting Binding Purchase Orders from COVAX Buyers; or
(c) a COVAX Buyer terminates its Supply Agreement with Novavax other than for reasons of convenience, a Force Majeure Event or force majeure as it may otherwise be defined in any Supply Agreement.
13. Term and Termination
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13.2 Termination Rights
13.2.1 Either Party (the “Terminating Party”) shall be entitled to terminate this Agreement at any time and with immediate effect by giving notice in writing to the other Party:
(i) in the event of a material breach by the other Party of any of its material obligations under this Agreement, provided that: (i) the material breach is not capable of remedy; or (ii) the Party being in material breach of its obligations fails to [***] within [***] or to [***] within [***] after being given written notice by the Terminating Party requiring such remedy;
(ii) if a Solvency–Related Event occurs in respect of the other Party; or
(iii) notwithstanding Clause 15, in the event that a Force Majeure Event continues for a period of at least [***] resulting in a non–performance or delay of the other Party’s performance under this Agreement due to the Force Majeure Event.
13.2.2 Gavi shall be entitled to terminate this Agreement at any time and with immediate effect by giving notice in writing to Novavax in the following circumstances:
(i) if the Purchase Condition is not satisfied by 31 December 2021;
(ii) if all Novavax Doses are not delivered to COVAX Buyers by 31 December 2022;
(iii) if Novavax withdraws any Emergency Use Authorisation or Regulatory Approval (or any application for Emergency Use Authorisation or Regulatory Approval), or if Novavax’s Emergency Use Authorisation or Regulatory Approval is revoked, or materially changed;
(iv) if Novavax ceases the manufacturing of Vaccine due to material safety, regulatory or ethical issues and does not restart such activity within [***];
(v) if there is a Supply Failure that cannot be remedied by the Remedial Plan in the timeline specified in Clause 7.2.3;
(vi) if Novavax is in breach of its obligations pursuant to Clause 7.1, provided that if the Parties disagree whether Novavax has used best endeavours or Commercially Reasonable Endeavours (as applicable), this shall be determined by an Expert pursuant to Clause 14.2;
(vii) if Novavax is in breach of its obligations pursuant to Clause 4;
(viii) if an audit conducted pursuant to Clause 10 has confirmed a Misuse of Funds or Prohibited Practice; or
(ix) if it has been established by a final judgment or a final administrative decision that Novavax has been guilty of a Prohibited Practice, involvement in a criminal organisation, money laundering or terrorist financing, terrorist related offences, child labour or other forms of trafficking in human beings or circumventing fiscal, social or any other applicable legal obligations, including through the creation of an entity for this purpose.
13.2.3 If a Party, in good faith, considers the conditions of a Stop Criterion to be met, it shall notify the other Party thereof (the “Safety Notice”).
(i) Following the submission of the Safety Notice, and upon the written request of the other Party, the Parties shall confer within a period of [***] (the “Consultation Period”) to review and discuss the existence of a Stop Criterion.
(ii) If the Parties, after expiry of the Consultation Period, disagree on the existence of a Stop Criterion, an Expert shall determine pursuant to Clause 14.2 whether the conditions of a Stop Criterion are met.
(iii) Within [***] after the Parties have reached agreement on the existence of a Stop Criterion or the Expert determination was rendered confirming the existence of a Stop Criterion, Gavi shall be entitled to terminate this Agreement [***] by giving notice in writing to Novavax.