Master Alliance Provisions Guide (MAPGuide)

Fiocruz – AstraZeneca, COVID-19 Technological Order Agreement

  • Liability | Representations & Warranties

7. Representations and Warranties

7.1 [Each Party warrants that]:

[…]

IV – all the consents, approvals and permissions of all governmental authorities or third parties necessary to sign this Agreement were obtained by the Parties. They further recognize that other consents, approvals and authorizations from governmental authorities or third parties may be required for the performance of the Object of the Agreement.

V – the execution and delivery of this Agreement, Exhibits, as well as all other instruments and documents related to this Agreement, and the execution of the Object will in no way (i) conflict with or violate any organizational/corporate documents of the Parties; (ii) results in breach of any contract to which it is a party; or (iii) violate any applicable law, rule or regulation;

VI – will not infringe the intellectual property rights of third parties in the manufacture, commercialization, promotion or sale of a Finished Vaccine;

VII – has no interest in the tobacco industry, illicit drugs, arms dealing, gambling operations, the promotion of violence or any illegal activitis including slavery, human trafficking and the use of child labor.

7.2 The Contracting Parties specifically declare and guarantee that they:

I – are aware that the development of Covid-19 Vaccine is an activity that involves Technological Risk (as defined in clause 9.15 below) and, therefore, there is a chance that the results of clinical research related to the Covid-19 Vaccine will be negative, which will make it impossible to comply with the Object of this Agreement, specifically with regard to the delivery of IFA [API]. There is also a chance that IFA process development may encounter unforeseen challenges requiring mitigation that could delay delivery of IFA. In case the result of the development of the Covid-19 Vaccine is negative, the provisions of clause 9.15 below shall apply. For the purposes of this Agreement, the Technological Risk must adopt the definition established in Federal Decree no. 9,283/2018, that is, “possibility of failure to develop a solution, resulting from a process in which the result is uncertain due to insufficient technical-scientific knowledge at the time when the action is decided” […]

7.3 Contractor specifically declares and warrants that:

I – up to the time of the delivery of the total IFA, provided for in this Agreement, under the terms of clause 10, it will comply with the determinations established in Exhibit V, in the legislation and regulations and rules of Good Manufacturing Practices applicable, as well as in accordance with the legislation, standards or regulations that may change or replace those currently in force;

II – until the date of signature of this Agreement, it has not received any adverse communication from the regulatory authority in relation to the facilities that will produce the IFA Object of this Agreement, including in relation to the compliance of the installations with all applicable Good Manufacturing Practices requirements. The Contractor shall communicate as soon as it becomes aware of the Contracting Parties any adverse communication from any regulatory authority in relation to the facilities where the IFA, Object of this Agreement, will be produced;

III – it will spend its best efforts so that the delivery of the IFA takes place in accordance with the conditions provided for in this Agreement; and

IV – the execution of the activities foreseen in this Agreement to attend to its Object, which includes the final processing of the IFA to obtain the Finished Vaccine and the supply of it exclusively to attend the demands of the Ministry of Health, do not constitute violation or misappropriation intellectual property rights of others.