3. Contracting Parties Obligations
3.1 [the Contracting Parties will]
VII – be, operationally and technically, able to receive the Contractor’s technology, and must obtain and maintain, at the Contracting Parties expense and responsibility, including all government authorizations necessary for the manufacturer of the Finished Vaccine, in accordance with the specifications provided by Contractor in the Exhibits to this Agreement;
VIII – possess or acquire, at the expense thereof, all the resources, facilities, knowledge and personnel necessary to build and operate the facility, and to manufacture and sell the Finished Vaccine as required by the Agreement;
IX – to pay, at its exclusive expense, with all the necessary investments to adapt the existing facilities and/or build new facilities (“Final Installations”), purchase equipment, materials and instruments necessary to receive the production technology of the Finished Vaccine, in the terms prepared by Contracting Parties, and confirmed by Contractor, contained in the Exhibits to this Agreement;
X – ensure that the Final Installations are adequate to conduct all operations/manufacturing steps, in accordance with current legislation;
XI – manufacture the Finished Vaccine in accordance with the specifications set out in this Agreement and its Exhibits, in particular Exhibit II and Exhibit V, and in the applicable Good Manufacturing Practice standards;
XII – to be responsible for all the necessary procedures for the importation of the IFA, and to bear all direct of indirect costs for that purpose since the receipt of the IFA at the port of destination, pursuant to the Exhibit II; and
XIII – create, receive Contractor approval, and execute accordingly an end-to-end program plan that outlines the necessary actions , documents, and other deliverables required to successfully produce the aforementioned quantities of COVID-19 Vaccine
4. Contractor Obligations
4.1 [The contractor will]
I – undertake all commercially reasonable efforts to perform the contracted Object, with the allocation of qualified professionals having appropriate technical knowledge, providing the appropriate facilities, materials, equipment and technologies, all in accordance with the relevant legislation, including technical standards, health and occupational safety, in accordance with Exhibit I.
14. Assignment and Subcontracting
14.5 The manufacturing of the Finished Vaccine by Contracting Parties cannot be outsourced to any company, even if this is duly authorized to operate in the national territory, without the prior written authorization of Contractor.
15. Transfer of Technology and Intellectual Property
15.1 Contractor shall transfer the total technology for the production process of the Covid-19 Vaccine in order to enable Contracting Parties to production and the field of technology, in two stages: 1. for the final processing of the Covid-19 vaccine and 2. for the production of IFA [API].
15.2 In the first stage, Object of this Agreement, the Contractor shall transfer the knowledge and planning available for the final processing of the Covid-19 Vaccine in accordance with the provisions in Exhibit I of this Agreement, in order to enable Fiocruz to carry out the final processing of the Covid-19 Vaccine in its facilities and supplying the Finished Vaccine, exclusively to meet the demands of the Ministry of Health, using the IFA acquired from the Contractor, as provided in this Agreement and its exhibits.
15.2.1 Exclusively for the execution of the provisions of this clause, and subject to the success of the activities described in Exhibit I and the fulfillment of the obligations provided for in this Agreement, the Contractor will free license or sublicense, non-exclusively without the right to grant sublicenses, licensed intellectual property rights to Contractor or Contractor ownership which are required for the production of the Finished Vaccine under the terms of Exhibit III to this Agreement.
15.3 Issues related to the stage of knowledge transfer of the IFA production process, will be the object of a specific contract called the Technology Transfer Agreement (“CTT”). Such a contract will be negotiated in a manner compatible with the duties of cooperation, loyalty and objective good faith, and shall be executed no later than ninety (90) days after the signature of this Agreement, observing the following assumptions: [redacted].