Provision Language
1.4 Entry into Force and Duration of the APA
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I.4.3. During the term of this APA, the contractor shall not enter into any agreements or accept any commitments which would impede the contractors ability to fulfil its main performance obligations under this APA.
I.8 Allocation and Vaccine Order Forms
I.8.1 The Initial European Doses will be allocated by the Commission among the participating Member States according to a population distribution key, unless a different allocation would be communicated by the Commission to the contractor. The contractor will plan deliveries to each participating Member State in accordance with the allocation key communicated by the Commission pursuant to the foregoing sentence. In order to avoid too small deliveries which could put the supply chain at risk and increase complexity and costs of the deliveries, the Parties agree that the minimum size per delivery will be the lower of either 1,000,000 doses or 12% of the total number of doses allocated to the relevant participating Member State in accordance with the first sentence of this Article.
I.8.2 The Commission will formally notify to the contractor the volumes of the Product allocated to each participating Member State under this APA within thirty (30) calendar days after entry into force of this APA. This formal notification is binding upon all Parties.
I.8.3 The Commission will allocate the Additional European Doses between the participating Member States in accordance with the principles set out above in Article I.8.1 and will formally notify the allocation decision to the contractor within thirty (30) calendar days following its order of the Additional European Doses. This formal notification is binding upon all Parties.
I.8.4 Following the formal notification of the allocation decision by the Commission pursuant to Article I.8.2 or I.8.3 above, as the case may be, the participating Member States and the contractor will conclude Vaccine Order Forms using the template Vaccine Order Form attached to this APA as Annex II. The purpose of these Vaccine Order Forms is to specify further details of the delivery to the respective participating Member State, such as the place of delivery (the “specific deliveries”). Each Vaccine Order Form shall be signed by the relevant representative of the participating Member State and the contractor.
The participating Member States shall send the completed and duly signed Vaccine Order Form attached to this APA as Annex II, within fifteen (15) calendar days after the Commission formally notifies to the contractor its allocation decision. The terms of such Vaccine Order Form, in particular but without limitation, the volume stated therein, shall be aligned with – and do not affect in any manner – the overall volumes, dates and phasing set forth in the delivery schedule set out in Article I.11 below. Within ten (10) calendar days as of receipt of a Vaccine Order Form in compliance with the terms of this APA, in particular the allocation decision of the Commission and the delivery schedule set out Article I.11 below, the contractor will send back to the participating Member States the Vaccine Order Form duly signed and dated.
I.10 Right of the Participating Member States to Resell, Export and/or Distribute the Product
I.10.1 The participating Member States will be entitled to re–sell, export and/or distribute any of the Products supplied to them pursuant to this APA to any other EU or EEA Member State and Switzerland, provided however that such re–sale, export and/or distribution may not take place before the concerned other EU or EEA Member State or Switzerland expressly agrees in writing to fully assume the indemnity obligations as set out under Article I.23 below and to provide a formally executed confirmation to the contractor.
I.10.2 The participating Member States shall take the appropriate measures to ensure that the Products supplied to them pursuant to this APA will not be (i) re-sold or (ii) exported, distributed or donated for free to another country outside the EU and EEA and Switzerland, including for donation via NGOs or the World Health Organization, without prior consent of the contractor.
I.10.3 The contractor is free to grant or withhold its consent to a re–sale pursuant to Article I.10.2 (i) at its own discretion, it being understood, however, that (i) no re-sale pursuant to Article I.10.2 (i) shall take place at a price higher than the Purchase Price as agreed in this APA and (ii) no re–sale pursuant to Article I.10.2 (i) shall take place unless the receiving country first confirms to the satisfaction of the contractor (i) that it will fully assume the indemnity obligations as set out under Article I.23 below or, alternatively, that there are other protection arrangements that the contractor accepts as being adequate (such acceptance not to be unreasonably withheld) and (ii) that the indemnity by the receiving country or other protection arrangement (as the case may be) is equivalent to the rights of the contractor under Article I.23 below, both from a legal and commercial perspective. The Parties acknowledge that, should re–sale to any third country, including EEA Member States and Switzerland, take place the participating Member State reselling doses has an obligation to reimburse the Commission the up–front payment per dose paid by the Commission to the contractor.
I.10.4 The contractor shall not unreasonably withhold its consent to the export, distribution or donation for free pursuant to Article I.10.2 (ii), it being understood, however, that no export, distribution or donation pursuant to Article I.10.2 (ii) shall take place unless the receiving country first confirms to the satisfaction of the contractor (i) that it will fully assume the indemnity obligations as set out under Article I.23 below or, alternatively, that there are other protection arrangements that the contractor accepts as being adequate (such acceptance not to be unreasonably withheld) and (ii) that the indemnity by the receiving country or other protection arrangement (as the case may be) is equivalent to the rights of the contractor under Article I.23 below, both from a legal and commercial perspective.
I.10.5 In addition, the participating Member State envisaging a re–sale, export, distribution or donation pursuant to Articles I.10.1 or I.10.2 shall ensure, at its expense or at the expense of the receiving country, that the required regulatory/quality/GMP/GDP processes to enable such re–sale, export, distribution or donation (i.e. for the transport of the Product from the participating Member State envisaging such re–sale, export, distribution or donation to the central warehouse of the receiving country) are in place, for instance as pertains to (re)- labelling, validated transportation or cold chain integrity assurance. For the avoidance of doubt, the participating Member State envisaging such re–sale, export, distribution or donation shall bear (or have the receiving country bear) any liabilities, claims, costs (including costs for the transport of the Product from the participating Member State envisaging such re–sale, export, distribution or donation to the central warehouse of the receiving country), damages and other losses resulting from such re–sale, export, distribution or donation.
I.10.6 In case of a donation or a re–sale to another EU or EEA Member State or Switzerland, the contractor may, at its sole discretion and without incurring additional costs, attempt to support or execute implementation of regulatory/quality/GMP/GDP requirements, particularly if the Products have not yet been delivered to the participating Member State.