II.14 Termination of the APA
II.14.1 Grounds for Automatic Termination of the APA. The APA will be automatically terminated if and when the contractor notifies the Commission of its inability to provide the Product because of, and only because of, the following reasons: (i) the clinical trial results not being satisfactory, (ii) the clinical trial results not meeting their end point in terms of efficacy or safety or (iii) the EU marketing authorisation not being granted. The notification of the contractor shall set out in detail the underlying reasons for automatic termination of the APA. The termination will be effective unless the Commission objects in writing within thirty (30) calendar days following the notification by the contractor, such objection may only be issued based on reasonable grounds given the evidence of one the three reasons (points (i) through (iii)) stated above and taking into account the severity of the impact that the continuation of the APA would have on the contractors business. If and once the termination becomes effective the contractor may not sell and/or deliver the Product to any third party.
II.14.2 Grounds for Termination by the Commission or the Participating Member State. The Commission, acting on behalf and in the name of the participating Member States, may terminate the APA in the following circumstances (a) through (h), and the participating Member States may terminate their respective Vaccine Order Forms in the following circumstances (b) through (h). Except for the termination right in case of (a) below, a right of termination only exists if the reason giving rise of the right to terminate is not cured, removed or otherwise no longer existent within [redacted content] calendar days of receipt by the contractor of formal notification from the Commission of the intention to terminate the APA or participating Member States to terminate the respective Vaccine Order Forms, which formal notification shall include a reasonably detailed description of the alleged breach.
(a) If no EU marketing authorisation is granted by [redacted content], or any other day mutually agreed upon by the Commission and the contractor in writing or if by that date no doses of the Initial European Doses have been supplied to any of the participating Member States. If the contractor expects that such a situation may occur, it will inform the Commission well in advance of such possibility, explain the reasons behind such delays and, if possible, propose a remedy for the situation, including a revised delivery schedule.
(b) If the contractor is in material breach of obligations (i) in relation to the main performance obligations such as the obligations under [redacted content] (ii) in relation to the obligations under [redacted content] or (iii), in the case of a participating Member State, in relation to the obligations under a Vaccine Order Form, or if the contractor [redacted content] refuses to sign one or several Vaccine Order Form(s).
(c) If the contractor is in one of the situations provided for in points (a) and (b) of Article 136(1) of the Financial Regulation.
(d) If the contractor, any of the members of its management board or any of its key employees involved in the performance of this APA is in one of the situations provided for in points (c) to (h) of Article 136(1) or to Article 136(2) of the Financial Regulation.
(e) If the procedure for awarding the APA or the performance of the APA prove to have been subject to irregularities or fraud on the part of the contractor.
(f) If the contractor is in a situation that constitutes a conflict of interest or a professional conflicting interest and such situation is not resolved by the contractor in accordance with Article II.5.2.
(g) If a change to the contractor’s legal, financial, technical, organisational or ownership situation substantially affects the performance of the APA or substantially modify the conditions under which the APA was initially awarded or a change regarding the exclusion situations listed in Article 136 of Regulation (EU) 2018/1046 that calls into question the decision to award the contract.
(h) In the event of force majeure, where either resuming implementation is impossible or the necessary ensuing amendments to the APA or a Vaccine Order Form would mean that the tender specifications are no longer fulfilled or result in unequal treatment of tenderers or contractors.
II.14.3 Grounds for Termination by the Contractor. The contractor may terminate the APA or the respective Vaccine Order Form in the following circumstances:
(a) If the Commission or any of the participating Member States [redacted content].
(b) In the event of force majeure, where either resuming implementation is impossible or the necessary ensuing amendments to the APA or a Vaccine Order Form would mean that the tender specifications are no longer fulfilled or result in unequal treatment of tenderers or contractors.
II.14.4 Procedure for Termination. The contractor or the Commission (as the case may be) must formally notify the Commission or the contractor (as the case may be) of its intention to terminate the APA. The foregoing sentence shall apply mutatis mutandis to the Vaccine Order Forms, it being understood, however, that formal notification shall be issued by or to (as the case may be) the relevant participating Member State.
The Party receiving a termination notice pursuant to the foregoing paragraph shall have thirty (30) calendar days following the date of receipt to submit observations, including the measures it has taken or will take to continue fulfilling its contractual obligations. Failing that, the decision to terminate becomes enforceable the day after the time limit for submitting observations has elapsed.
If the other Party submits observations, the Party intending to terminate must formally notify it either of the withdrawal of its intention to terminate or of its final decision to terminate.
In the cases referred to in points (a) to (c), (f) and (g) of Article II.14.2 and in Article II.14.3, the date on which the termination takes effect must be specified in the formal notification.
In the cases referred to in points (d), (e) and (h) of Article II.14.2, the termination takes effect on the day following the date on which the contractor receives formal notification of termination.