Master Alliance Provisions Guide (MAPGuide)

Peru Ministry of Health – Pfizer/BioNTech, COVID-19 Vaccine Binding Term Sheet

  • Liability | Indemnification & liability

Indemnification & Liability Protection (Page 6–7)

The Definitive Agreement will include the Indemnification Provision in Appendix A hereto. 

Liability Protection. In view of the exceptional circumstances which characterize the rapid development and scale–up of a COVID–19 vaccine, as a condition to entering into this Binding Term Sheet, MoH represents that it has adequate statutory and/or regulatory authority and adequate funding appropriation to undertake and completely fulfill the indemnification obligations and provide adequate protection to Supplier and its affiliates from liability for claims arising out of or in connection with the vaccine or its use. Further, MoH will satisfactorily demonstrate this, in Suppliers’ sole discretion, with true and complete documentary support to be provided to the Supplier prior to execution of this Binding Term Sheet. 

MoH hereby covenants and acknowledges and agrees that a condition precedent for the supply of Vaccine requires that MoH shall implement such statutory or regulatory requirements or funding appropriation sufficient to meet its obligations in this Binding Term Sheet prior to supply of Vaccine by Supplier or its affiliates. 

Definitive Agreement shall include term confirming that MoH shall not seek contribution or indemnity from Suppliers for claims which if brought against Suppliers directly, MoH would indemnify Suppliers under this Agreement.

Appendix A Full Liability & Indemnity for the Definitive Agreement

For the purposes of this Appendix A, Vaccine shall include (a) all vaccines manufactured in whole or in part, or supplied directly or indirectly, by or on behalf of Pfizer or BioNTech or any of their Affiliates pursuant to this Agreement that are intended for the prevention of the human disease COVID–19 or any other human disease, in each case which is caused by any of the virus SARS–CoV–2 and or any or all related strains, mutations, modifications or derivatives of the foregoing, (b) any device, technology or product used in the administration of, or to enhance the use or effect of such vaccine, or (c) any component or constituent material of (a)-(b).  

Indemnification by Government.  Government hereby agrees to indemnify, defend and hold harmless Pfizer, BioNTech, each of their Affiliates, contractors, sub–contractors, licensors, licensees, sub–licensees, distributors, contract manufacturers, services providers, clinical trial researchers, third parties to whom Pfizer or BioNTech or any of their respective Affiliates may directly or indirectly owe an indemnity based on the research, development, manufacture, distribution commercialization or use of the Vaccine, and each of the officers, directors, employees and other agents and representatives, and the respective predecessors, successors and assigns of any of the foregoing (“Indemnitees”) from and against any and all suits, claims, actions, demands, losses, damages, liabilities, settlements, penalties, fines, costs and expenses (including reasonable attorneys’ fees and other expenses of an investigation or litigation) whether sounding in contract, tort, intellectual property, or any other theory, and whether legal, statutory, equitable or otherwise (collectively “Losses”) arising out of, relating to or resulting from the Vaccine, including but not limited to any stage of design, development, investigation, formulation testing, clinical testing, manufacture, labeling, packaging, transport, storage, distribution, marketing, promotion, sale, purchase, licensing, donation, dispensing, prescribing, administration, provision or use of the Vaccine. 

Assumption of Defense by Government. The indemnitee(s) shall notify Government of Losses for which it is seeking indemnification pursuant hereto (“Indemnified Claims”). Upon such notification the Government shall promptly assume conduct and control of the defense of such Indemnified Claims with counsel acceptable to Indemnitee(s), whether or not the Indemnified Claim is rightfully brought; provided, however, that the Government shall provide advance notice in writing of any proposed compromise or settlement of any Indemnified Claim and in no event may Government compromise or settle any Indemnified Claim without Indemnitee(s)’s prior written consent, such consent not to be unreasonably withheld. Indemnitee(s) shall reasonably cooperate with Government defense if the Indemnified Claims.

Each Indemnitee shall have the right to retain its own counsel and to participate in the Government’s defense of any Indemnified Claim, at its own cost and expense except as set forth below. A failure by the Indemnitee(s) to give notice and to offer to tender the defense of the action or suit pursuant to this section shall not limit the obligation of the Government under this Article, except and only to the extent the Government is actually prejudiced thereby.

Assumption of Defense by Pfizer and BioNTech. Notwithstanding the foregoing, Pfizer and BioNTech may elect to assume control of the defense of an Indemnified Claim (a) within thirty (30) days of Indemnitee’s notice to Government of the Indemnified Claim or (b) at any time if, in Pfizer and BioNTech’s sole discretion, (i) the Government fails to timely assume the defense of or reasonably defend such Indemnified Claim(s) to the satisfaction of Pfizer and BioNTech or (ii) Pfizer and BioNTech believe in good faith that a bona fide conflict exists between Indemnitee(s) and Government with respect to an Indemnified Claim hereunder. Upon written notice of such election, Pfizer and BioNTech shall have the right to assume control of such defense and the Government shall pay (as incurred and on demand), all Losses including the reasonable attorneys’ fees and other expenses incurred by Indemnitee(s)m in connection with the Indemnified Claim, In all events, the Government shall cooperate with Indemnitee(s) in the defense settlement or compromise of the Indemnified Claim. 

Costs and expenses, including fees and disbursements of counsel, incurred by the Indemnitee(s) in connection with any Indemnified Claim shall be reimbursed on a quarterly basis by the government, without prejudice to the Government’s right to refund in the event that the Government is ultimately held in a final non–appealable judgement to be not obligated to indemnify the indemnitee(s).Privileges and Immunities. For the purposes of this clause, “Privileges and Immunities” shall mean any privileges, immunities or legislation in Peru, including no–fault vaccine compensation programs, pandemic insurance programs, immunities from suit or liability, or any protections, defenses, or limitations –of–liability (whether statutory, regulatory, common law, or otherwise), existing or future, that may separately protect Indemnitees from Losses. Government acknowledges that its indemnification obligations under this Agreement are (1) expressly in addition to, and not limited by, any Privileges and Immunities, and (2) do not waive or relinquish Indemnitees’ rights to any Privileges and Immunities.