Master Alliance Provisions Guide (MAPGuide)

European Commission – AstraZeneca, COVID-19 Vaccine Advance Purchase Agreement

  • Liability | Indemnification & liability

6. Acquisition of Materials and Services

6.2 Capacity Limitations. In the event AstraZeneca’s ability to fulfill its obligations under this Agreement is impeded by a competing agreement entered into by or on behalf of the Commission, AstraZeneca shall promptly inform the Commission. While AstraZeneca shall continue to use Best Reasonable Efforts to engage with its own contract manufacturers and suppliers to utilize the capacity and/or components, the Commission will assist in finding a mutually acceptable solution for this Agreement and the competing agreement. To the extent AstraZeneca’s performance under this Agreement is impeded by any such competing agreements, AstraZeneca shall not be deemed in breach of this Agreement as a result of any such delay due to the aforementioned competing agreement(s).

14. Indemnification

14.1 Member States. Each Participating Member State shall indemnify and hold harmless AstraZeneca, its Affiliates, subcontractors, licensors, sub-licensees, and officers, directors, employees and other agents and representatives of each (collectively, the “Indemnified Persons”) from and against any and all damages and liabilities, including settlements for which the Indemnifying party has given its consent pursuant to Section 14.2, and necessary legal costs relating to, resulting from or associated with claims for death, physical, mental, or emotional injury, illness, disability, or condition, fear of the foregoing, property loss or damage, and business interruption of the injured party or a Related Person of such injured person (together, “Losses”) relating to or arising from the use or administration of the Vaccine shipped or allocated to its jurisdiction. Such indemnification will be available regardless of where the Vaccine is administered, where the claim is brought, and whether the claim of a Defect originates from the distribution, administration and use, clinical testing or investigation, manufacture, labelling, formulation, packaging, donation, dispensing, prescribing or licensing of the Vaccine in its jurisdiction. Such indemnification will not be available to Indemnified Persons (a) to the extent such Losses are the result of such Indemnified Person’s Willful Misconduct, or (b) to the extent that there has been a final determination by a court of competent jurisdiction that a defect in the Vaccine has arisen from AstraZeneca’s failure to comply with current Good Manufacturing Practices or EMA pharmacovigilance regulations.

Indemnification under this Section 14.1 will be available for Losses arising from the use and administration of vaccines supplied under this Agreement, regardless of when or where vaccination occurred and regardless of when or where the injury leading to the Losses occurs or is reported.

14.2 Process. The Indemnified Person shall give (or cause AstraZeneca to give) the Participating Members State(s), as applicable (the “Indemnifying Party”), prompt notice of any claim or lawsuit served upon the Indemnified Person (a “Third Party Claim”) stating the nature and basis of such Third Party Claim and the maximum estimated amount (in euro) of such Third Party Claim, to the extent known (which estimate may be updated from time to time). Notwithstanding the foregoing, no delay or deficiency on the part of the Indemnified Person in so notifying the other shall limit any right of any Indemnified Person to indemnification under this Article 14, except to the extent such failure materially prejudices the defense of such Third Party Claim. The Indemnified Person shall assume and control the defense of any Third Party Claim using legal counsel reasonably chosen by the Indemnified Person. Each of the Parties shall (i) use commercially reasonable efforts to mitigate the effects of the claim and (ii) fully cooperate with the Indemnified Person and its legal representatives in the investigation and defense of any matter which is the subject of indemnification, at the Indemnifying Party’s cost and expense. The Indemnified Person shall keep the Indemnifying Party reasonably informed of the progress of the defense of the Third Party Claim. The Indemnifying Party shall pay the invoices of legal counsel and other expenses of the Indemnified Person arising from defending the Third Party Claim promptly upon presentment of an invoice and in any case within ninety (90) days of presentment thereof. The Indemnified Person shall have the right to seek settlement or compromise of, and to so settle or compromise, the Third Party Claim; provided that the Indemnified Person shall not settle or compromise a Third Party Claim without the prior written consent of the Indemnifying Party and the Indemnifying Party shall not unreasonably withhold, condition or delay its approval of the settlement of any claim, liability or action covered by this Article 14. 

15. Release; Limitation of Liability for claims other than third party indemnification; Disclaimer of Warranties

15.1 Release. The Commission and each of the Participating Member States each within their respective competencies, on behalf of itself, waive and release any claim against AstraZeneca arising out of or relating to: (a) lack of safety or efficacy of the Vaccine, subject to compliance by AstraZeneca with applicable EU regulatory requirements for a pandemic product, limited to manufacture by AstraZeneca of the Vaccine in accordance with Good Manufacturing Practices; (b) use or administration of the Vaccine under pandemic conditions, except to the extent such claim arises from AstraZeneca’s wilful misconduct or failure to comply with EU regulatory requirements applicable to the Vaccine including manufacture by AstraZeneca of the Vaccine in accordance with Good Manufacturing Practices; (c) issues relating to storage or transport conditions including deep cold chain storage; (d) lack of proper aseptic technique or dosing at the point of administration of the Vaccine; or (e) delays in delivery of the Vaccine under this Agreement. 

15.2 Limitation of Liability for claims other than third party indemnification. The aggregate liability of AstraZeneca and its Affiliates in respect of claims made by the Commission or Participating Member States, or any affiliates acting on the Commission or Participating Member States’ behalf (as distinguished from claims for third party indemnification), whether for breach of contract, another contractual-based claim, arising in tort (including negligence) or otherwise arising out of, under or in connection with this Agreement shall not exceed the amounts actually paid by the Commission and Participating Member States to AstraZeneca under this Agreement.

15.3 Disclaimer of Warranties. The Parties acknowledge that they are not relying on any understanding, arrangement, statement, representation (including, any negligent misrepresentation but excluding any fraudulent misrepresentation), warranty, condition, term, customary practice, course of dealing or provision except for the warranties set out in this Agreement. All statements, representations, warranties, terms, conditions and provisions (including, any implied by statute or equivalent, case law or otherwise and any implied warranties and/or conditions as to merchantability, satisfactory quality, fitness for purpose and skill and care), other than fraudulent misrepresentations and the provisions set out in this Agreement, are hereby excluded to the maximum extent permissible by law.

17. Data protection

17.2 Processing of personal data by the Parties

[…]

In the event a Party suffers a personal data breach, such Party shall ensure it complies with Applicable Laws regarding Data Protection and, if applicable, complies with any obligations to notify Data Protection Supervisory Authority, data subjects or other regulatory bodies as required by Applicable Law regarding the Personal Data Breach.

To the extent the Commission or Participating Member State suffers a personal data breach that (1) has an impact on the services provided under this Agreement or (2) relates to In-Scope Personal Data AstraZeneca shared with the Commission or Participating Member State, the Commission or Participating Member State shall promptly notify AstraZeneca about such personal data breach.

Both Parties shall indemnify, defend, and hold each other harmless from and against any and all liabilities, claims, losses, suits, judgments, and reasonable legal fees arising from any breach, negligent act, error or omission of relevant data protection obligations under this Agreement by the other Party, its subcontractors or their respective personnel.