Master Alliance Provisions Guide (MAPGuide)

CEPI – VBI, COVID-19 Vaccine Development Funding Agreement

  • Liability | Indemnification & liability
  • Liability | Insurance

<p>“<b>Enabling Rightsb>” means rights to <a class=”ghiaakeytermlinktitle=”click for definitionhref=”” datatermid=”123“>Background Intellectual Propertya>, <a class=”ghiaakeytermlinktitle=”click for definitionhref=”” datatermid=”220“>Project Intellectual Propertyaand <a href=”#kt“>Project Resultsa> that could be asserted by Awardee or a Subawardee to block CEPI from exercising the Public Health Licence to make, have made, use, have used, import, sell or otherwise exploit the Project Vaccine. For purposes of this Agreement, Enabling Rights also includes the contractual rights that control the use of such items as, for example, rights to use biological materials covered in material transfer agreements entered into between Awardee and third parties.p>
<p><span style=”textdecoration: underline;”><strong>18. Insurance, Liability and Indemnificationstrong>span>p>
<p><strong>18.1 Insurance.strong> Awardee shall maintain insurance sufficient to cover the activities, risks, and potential omissions relevant to the Project, including clinical trial liability insurance cover, in accordance with generally accepted industry standards and as required by law. Awardee shall provide CEPI with a certificate confirming such insurance upon request. In the event that the <span style=”textdecoration: underline;”><a href=”” target=”_blankrel=”noopener“>Public Health Licencea>span> becomes exercisable and CEPI exercises such rights, CEPI shall maintain comparable insurance protection.p>
<p><strong>18.2 Indemnification for Third Party Claims.strong> Awardee shall indemnify and defend CEPI, its Affiliates, officers, directors, third party contractors, and employees, from and against any and all damages, and liabilities arising from claims asserted by third parties (including claims for negligence) which arise directly or indirectly out of or in connection with: (i) a breach of Awardees, or its Affiliates or Subawardees obligations under this Agreement; (ii) the research, development, manufacture, promotion or use of any Project Vaccine, Project Results or Enabling Rights (including for clarity, the use of any Project Results in development activities and clinical studies) conducted by Awardee, or its Affiliates or Subawardees; or (iii) any claim that the use of Awardees <a href=”#kt“>Intellectual Property Rightsa> infringe the intellectual property rights of any third party, except to the extent such claim, damage or liability is caused by CEPIs negligence or intentional misconduct. In the event that the Public Health Licence becomes exercisable and CEPI exercises such rights, the obligations of this Clause 18.2 shall apply to CEPI <em>mutatis mutandisem>.p>
<p><strong>18.3 Conduct of Responses to Third Party Claims.strong> Each Party shall use all reasonable endeavours to inform the other Party promptly of any circumstances that are likely to give rise to a third party claim which may be covered by Clause 18.2 together with copies of all relevant papers and official documents. The indemnified party shall not take any material action in respect of any third party claim which is covered by Clause 18.2 without the consent of the indemnifying party, including any settlement of any such third party claim, provided such consent is not unreasonably conditioned, withheld or delayed. The indemnifying party shall have the right to assume control of defence of the claim and shall keep the indemnified party fully informed of the progress of all relevant third party claims which are covered by Clause 18.2 and shall fully consult with the indemnified party on the nature of any defence to be advanced in advance. The indemnified party may have its counsel participate in (but not control) the defence of a claim, at the indemnified partys own expense.p>
<p><strong>18.4 Exclusions.strong> Except in the event of a breach of a Partys confidentiality obligations under Clause 19, neither Party shall be liable to the other Party for any loss of profits or economic loss; or indirect, incidental or consequential damages, whether in contract, warranty, negligence, tort, strict liability or otherwise, arising out of or in connection with any breach of or failure to perform any of the provisions of this Agreement.p>
<p><strong>18.5 Liability Cap.strong> CEPIs maximum liability in aggregate to Awardee arising out of this Agreement shall not exceed the aggregate of the total Work Package budget unless CEPI has exercised the Public Health Licence in which event CEPIs maximum liability to Awardee arising out of this Agreement shall not exceed the greater of: (i) the aggregate of the total Work Package budget or (ii) CEPIs total insurance cover for any clinical trials or provision of Project Vaccine under the Public Health Licence.p>
<p><strong>18.6 Exclusions from Liability Cap.strong> Notwithstanding the foregoing, nothing in this Agreement shall limit the liability of either Party in respect of: (i) personal injury or death arising out of that Partys negligence or intentional misconduct; or (ii) fraud or fraudulent misrepresentation or intentional misconduct.p>
<p><strong>18.7 Pandemic Insurance.strong> The Parties acknowledge that, as of the Effective Date, WHO is considering an insurance mechanism that would provide insurance cover for the suppliers of investigational products for use in the case of a <a href=”#kt“>PHEICa> declared by WHO. The Parties agree that, if and when this mechanism is established, they shall discuss in good faith the impact of such arrangements on the Partiesobligations under this Agreement and how it would apply to the supply of Project Vaccines.p>