I.23.1 The Commission, on behalf of the participating Member States, declares that the use of the Products delivered under this APA and/or the Vaccine Order Forms will happen under epidemic conditions requiring such use, and that the administration of the Products will therefore be conducted under the sole responsibility of the participating Member States.
I.23.2 The Parties further declare that the provisions contained in this indemnification clause, including the exceptions to the indemnification undertakings, reflect the exceptional circumstances of the COVID19 pandemic and the need to develop new vaccines at an unprecedented speed in order to allow for very large scale immunisation.
I.23.3 On this basis, each participating Member State shall indemnify and hold harmless the contractor, its Affiliates, sub-contractors and sub-licensees, including contract partners involved in the research, development (including pre-clinical and clinical testing), manufacturing and/or delivery; and officers, directors, employees and other agents, representatives and service providers of each (together, the “Indemnified Persons”) for liability incurred and normally borne by them relating to harm, damages and losses (together, the “Losses”) as further specified in Article I.23.5 arising from the use and deployment of the Products supplied to the participating Member State (or another entity appointed by that participating Member State) under this APA, irrespective of the time when the Losses occur.
I.23.4 Such indemnification will not be available to the Indemnified Persons to the extent that [REDACTED].
I.23.5 Indemnification pursuant to Article I.23.3 will only be available for Losses that consist of: (i) liability towards the injured Party [redacted content] for death, physical, mental or emotional injury, illness, disability, cost of care, property loss or damage, loss of earnings, and business interruption; and (ii) all reasonable and necessary costs related to such Losses including legal fees, expert fees and other litigation or settlement expenses.
I.23.7 In case liability has been incurred by the Indemnified Persons for Losses, the contractor shall give the participating Member State in question, or an independent expert as referred to in Article I.23.8, access to all information reasonably necessary for the participating Member State to indemnify the Indemnified Persons and to verify whether the above-mentioned conditions are fulfilled.
I.23.8 The participating Member State shall be allowed to access the information through an independent expert in the field of damage claims, in particular in the field of public health, subject to an obligation of strict confidentiality. In that case, the participating Member State shall notify the contractor in advance of its intention to use an expert and the identity of such expert. The contractor shall be allowed to object to the use of an expert within 30 days counted from such notification, if it puts forward reasonable grounds on the basis of which the specific expert in question should not be permitted access to such information, such as conflict of interest. In such case, the participating Member State shall be allowed to appoint a new independent expert and notify that expert to the contractor.
I.23.9 The contractor shall promptly inform the relevant participating Member State of any damage claims brought against any of the Indemnified Persons (a “Third Party Claim”), stating the nature and basis of the damage claim in question and, if possible, the estimated amount of damages. The contractor shall use reasonable efforts to keep the participating Member State informed of any developments relating to such Third Party Claim, including updates on the estimated amount of damages.
I.23.10 The contractor shall ensure that the Indemnified Persons take such commercially reasonable actions to avoid, defend or settle the Third Party Claim and to mitigate the liability incurred. Within [REDACTED] calendar days of the submission by the contractor of an invoice for such actually incurred Losses (also when they arise during the course of legal proceedings or settlement discussions), the participating Member State shall provide written confirmation to the contractor that it will indemnify such losses, subject to the conditions set out in the present indemnification clause, in particular the conditions set above. [REDACTED.] The contractor shall keep the participating Member State reasonably informed in relation to the Third Party Claim and the contractor may settle the Third Party Claim only with the prior consent of the participating Member State (such consent not to be unreasonably conditioned, withheld or delayed).
I.23.11 Alternatively, the contractor may request, to the extent possible under the applicable rules of procedure, the participating Member State to assume (with its own counsel and at its own costs) sole control of the defence or settlement of the Third Party Claim; provided that: (i) the participating Member State shall reasonably take the contractors interests into consideration and shall not settle such Third Party Claim without the prior written consent of the contractor (such consent not to be unreasonably conditioned, withheld or delayed); and (ii) the contractor shall have the right, but not the obligation, to participate in the defence or settlement of the Third Party Claim and to retain its own counsel in connection with such Third Party Claim at its own expense. [REDACTED.]
I.23.12 These provisions apply until a final determination by the competent courts of a ground for exception to the indemnification, as stipulated in Articles I.23.4. Any claims of contractor under this Article I.23 shall be time barred not earlier than [REDACTED] after the final expiration of all relevant statutes of limitation periods for the relevant Third Party Claim.
I.23.13 The Parties acknowledge and agree that the provisions of this indemnification clause are reasonable and necessary to protect the legitimate interest of the Indemnified Persons. However, if any provision in this clause were to be held to be illegal, invalid or unenforceable, in whole or in part, then such provision shall not be nullified but the Parties, including the participating Member States, shall be deemed to have agreed to such provision that conforms with the limitations imposed by applicable law and that is as close as possible to the original intention of the Parties and has the same or as similar as possible economic effect, and such provision shall be automatically reformed accordingly.
II.4.1. [REDACTED] the Commission and the participating Member States are not liable for any damage or loss caused by the contractor, including any damage or loss to third parties occurred during or as a consequence of the performance of the APA or any Vaccine Order Forms.
II.4.2. If required by the relevant applicable legislation, the contractor must take out an insurance policy against risks and damage or loss relating to the performance of the APA or any Vaccine Order Forms. Upon request, the contractor must provide evidence of insurance coverage to the Commission.
II.4.3. If a third party brings any action against the Commission or the participating Member State in connection with the performance of the APA or any Vaccine Order Forms, including any action for alleged breach of intellectual property rights, the contractor must provide reasonable assistance to the Commission or the participating Member State.