Master Alliance Provisions Guide (MAPGuide)

Fiocruz – AstraZeneca, COVID-19 Vaccine Technology Transfer Agreement

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5. Supply

5.02 Supply Plan

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c) Supply Reporting. Licensees will provide the JSC with written reports detailing its Supply activities under the Supply Plan at least ten (10) days in advance of each regularly scheduled JSC meeting. The Parties will discuss the status, progress and results of such Supply Activities under the Supply Plan at such regularly scheduled JSC meetings. Notwithstanding the foregoing, Licensees shall notify AstraZeneca promptly upon becoming aware of any information that would reasonably be expected to be material to the Supply of the Licensed Product in the Territory.

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5.06 Manufacturing Plan

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b) Manufacturing Reporting. Licensees will provide the JSC with written reports detailing its Manufacturing activities under the Manufacturing Plan at least ten (10) days in advance of each regularly scheduled JSC meeting. The Parties will discuss the status, progress and results of such Manufacturing Activities under the Manufacturing Plan at such regularly scheduled JSC meetings. Notwithstanding the foregoing, Licensees shall notify AstraZeneca promptly within a reasonable term upon becoming aware of any information that would reasonably be expected to be material to the Manufacturing of the Licensed Product in the Territory.

c) Manufacturing Records. Licensees will maintain complete, current and accurate records of all Manufacturing activities conducted by it hereunder and all information results in from such activities, which records shall include: (i) all records required to be maintained under Applicable Law; (ii) batch records, validation data, stability testing data and quality control data; (iii) a reasonably detailed description of the processes and procedures followed; and (iv) a description of the implementation of any relevant improvements.

7. Records, Reports and Inspections

7.01 Records; Reports

During the term of this Agreement and for a minimum period of three (3) years thereafter, Licensees shall keep detailed, accurate and up to date records and/or books accessible upon AstraZeneca’s request, showing the quantity, description and price of all the Licensed Product supplied by Licensees or any Sublicensees in each country, and all sums paid to Licensees or any Sublicensees in each case during the previous five (5) years. Licensees shall ensure that such records and/or books are sufficient to ascertain the calculation of the Sublicense Fee with respect to the Licensed Product supplied by Licensees and any Sublicenses in the Territory and the payments due to AstraZeneca under this Agreement.

7.02 Inspections

As agreed in this Agreement, Licensees shall furnish Quarterly Certificate from Licensee’s accounting department for the calculation of Sublicense Fee and Additional Fee as per Section 6.03.

7.03 Inspection Costs

Licensees shall bear all the costs for the Quarterly Certificates of Sublicence Fee and Additional Fee. In case AstraZeneca wishes to get the Quarterly Certificates verified, they shall do the same at their costs.