Master Alliance Provisions Guide (MAPGuide)

Fiocruz – AstraZeneca, COVID-19 Technological Order Agreement

  • Protecting & sharing information | Technology transfer

3. Contracting Parties Obligations

3.1 [the Contracting Parties will]

IV – refrain from practicing acts that interfere in the Contractor’s administration, such as:

a) not allowing or giving rise to acts of subordination, hierarchical bonds, accountability, application of sanctions and direct supervision of the Contractor’s employees;
b) not exercising the power of command over the employees of the Contractor, reporting only to the representatives or persons responsible thereof, except when the object of the Agreement requires direct notification for the execution of specific tasks previously described in the Agreement;
c) not directing the hiring of people to work for the Contractor or in any subcontractors;
d) not promoting or accepting the deviation of the Contractor’s workers’ functions, through the use of such workers in activities other than those provided for in the contractual Object and in relation to the specific function for which the worker was hired;
e) not considering the Contractor’s employees as occasional employees of the the actual Contracting Parties, especially for the purpose of granting daily allowances and transport tickets;
f) not setting the amount of the Contractor’s workers’ compensation to provide the services, except in specific cases in which professionals with a higher qualification/experience are needed than those who, on the market, are paid the basic salary of the category, as long as they are justified; and
g) not granting the Contractor’s workers the typical rights of public servants, such as recess, optimal day off point, among others.

[…]

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.

II – be responsible for the distribution, control and supervision of Contractor’s human resources allocated for the execution of the Agreement, and the provision of services does not create any employment relationship between Contracting Parties and Contractor’s employees, prohibiting any relationship between them that characterize personality and direct subordination.

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].