Master Alliance Provisions Guide (MAPGuide)

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

  • Liability | Indemnification & liability
  • Liability | Representations & Warranties

Indemnification & Liability protection (page 7–9)

The Definitive Agreement will include the indemnification provisions in Appendix A hereto.

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, MISPAS must demonstrate, in a manner satisfactory to Suppliers, that Suppliers and their affiliates will have adequate protection, as determined in Suppliers’ sole discretion, from liability for claims arising out of or in connection with the Vaccine or its use.

MISPAS represents that it has adequate statutory and/or regulatory authority and adequate funding to undertake and completely fulfill the indemnification obligations and provide adequate protection to Suppliers and its affiliates from liability for claims arising out of or in connection with the Vaccine or its use.  Further MISPAS will satisfactorily demonstrate this in Suppliers’ sole discretion, with true and complete documentary support to provide prior to the execution of the Definitive Agreement.  MISPAS hereby covenants and acknowledges and agrees that a condition precedent for the supply of Vaccine requires that MISPAS shall implement and maintain in effect such statutory or regulatory requirements or funding appropriation sufficient to meet its obligations in this Binding Term Sheet prior to the supply of Vaccine by Suppliers or its affiliates.

The Definitive Agreement shall include terms confirming that MISPAS shall not seek contribution or indemnity from Suppliers for claims for which, if brought against Suppliers directly, MISPAS would indemnify Suppliers under the Definitive Agreement.

In addition, MISPAS hereby covenants and acknowledges and agrees that, as a condition precedent to the supply of the Vaccine under the Definitive Agreement, said agreement shall be ratified and approved as a whole by the Dominican Congress.  MISPAS hereby covenants and acknowledges and agrees that both the form of this ratification and the sufficiency of the protections provided thereunder shall be in Suppliers’ sole discretion.

Moreover, MISPAS, on behalf of itself and the Dominican Republic guarantees that it has undertaken all necessary procedures and obtained all authorizations required so that this commitment to indemnify is valid, not limited to any amount or conditions that are not expressly defined in this Binding Term Sheet, and enforceable by the Suppliers without any additional obligations on the Supplier

Public Contracting (page 9 – 10)

This Binding Term Sheet serves the purpose of addressing the health emergency in the Dominican Republic as a result of the COVID–19 pandemic, in the understanding that it is of extreme urgency to the national interest to provide the Dominican population with the doses of the Vaccine. Therefore the execution of this Binding Term Sheet and whatever other agreements necessary to purchase the Vaccine, are exceptional cases under Article 6 of Law 340–06 on Public Contracting. MISPAS, in the exercise of its legal attributions, represents and warrants compliances with all regulatory requirements established in Law 340–06 and all other applicable laws to be able to sign this Binding Term Sheet and all other documentation related to it, including but not limited to the Definitive Agreement, and agrees to hold the Suppliers harmless of any claims and damages directly or indirectly resulting from an inaccuracy of this representation and warranty.

Further, MISPAS acknowledges, represents and warrants that it has obtained all necessary approvals required by Dominican laws to enter into this Binding Term Sheet pending Congressional Approval for the supply of the Vaccine as described in this Binding Term Sheet

Appendix A. Full Liability & Indemnity provision for the Definitive Agreement

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 Pfizer.  The Indemnitees (s) shall notify Government of Losses for which it is seeking indemnification pursuant hereto (“Indemnified Claims”) following such notification.  Pfizer (directly or through either one of its affiliates or BioNTech shall assume control for the defense of an Indemnified Claim within thirty (30) days of Indemnitee’s notice to Government of the Indemnified Claim.  The Government shall pay (as incurred and on demand) all Losses, including the reasonable attorneys’ fees and other expenses incurred by Indemnitee(s), 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 judgment 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, immunity or legislation by the Dominican Republic, including no-fault [illegible] compensation programs, pandemic insurance programs, immunities from statutory liability or any protections, defenses or limitations-of-liability, whether otherwise existing or future, that may separately reflect Indemnitees from Losses.  Government acknowledges that its indemnification obligations under this Agreement are (1) expressly in addition, and not limited by, any Privileges and Immunities, and (2) do not waive or relinquish Indemnitees rights to any Privileges and Immunities.