“Regulatory Approval” means in relation to the Territory, an approval (excluding any emergency use approvals or any equivalent in any country but including any Conditional Approval) granted by the appropriate Regulatory Authority, pursuant to RCD No. 55/2010 and RCD 415/2020, both issued by ANVISA, and updates thereof, or offer for sale and/or use, and to sell and/or supply the Licensed Product in that country.
4. Manufacturing and Regulatory
4.01. Regulatory Activity; Diligence
Licensees shall have the right and obligation to Develop the Licensed Product in the Territory at its own cost and expense consistent with the Objectives and the Regulatory Plan. Licensees will use its Best Efforts to Develop and obtain or amend, whatever the case may be at the time, a Regulatory Approval for the Licensed Product in the Territory.
4.02. Regulatory Plan
a) Regulatory Plan. Within thirty (30) days after the Effective Date, the Licensees (through the JSC) will submit a written plan setting forth all Regulatory Activities and activities to be taken in connection with obtaining Fiocruz post-approval change as manufacture of IFA [API] of the Regulatory Approval in the Territory, to be undertaken by or on behalf of Licensees and the estimated timelines applicable to such activities (the “Regulatory Plan”) to the JSC for approval. At all times during the Term, Licensees will Develop the Licensed Product in accordance with the Regulatory Plan. Notwithstanding Licensees being responsible for all regulatory activities, AstraZeneca, in good faith, will support Licensees to allow them to develop and obtain approval for Fiocruz post-approval change as manufacture of IFA of the Regulatory Approval in the Territory.
b) Amendments. The JSC will periodically review, and, as required, prepare amendments to the initial Regulatory Plan, for review and approval by the JSC. Once ultimately approved by the JSC, the amended Regulatory Plan will become effective and supersede the previous Regulatory Plan as of the date approved by the JSC. Amendments to the Regulatory Plan will only be effective if made pursuant to this Section 4.02(b).
c) Regulatory Reporting. Licensees will provide the JSC with written reports detailing its Regulatory Activities under the Regulatory Plan and the results of such activities at least five (5) days in advance of each regularly scheduled JSC meeting. The Parties will discuss the status, progress and results of such Regulatory Activities under the Regulatory 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 Regulatory Activities and obtaining Fiocruz post-approval change as manufacture of IFA of the Regulatory Approvals for the Licensed Product in each country within the Territory.
4.03. Pharmacovigilance Agreement
Within forty-five (45) days after the Effective Date the Parties will agree in good faith the terms of a pharmacovigilance agreement following, where applicable, the terms of the Pharmacovigilance Agreement executed by the Parties under the Technological Order Agreement.
4.04. Regulatory Records
Licensees will maintain complete, current and accurate records of all Regulatory Activities conducted by it hereunder, under its responsibility, and all data and other information resulting from such activities. Such records will fully and properly reflect all work done and results achieved in the performance of the Regulatory Activities in good scientific manner appropriate for regulatory and patent purposes.
Licensees shall have the right to prepare regulatory submissions in relation to, and conduct all communications with all Regulatory Authorities in the Territory with regard to, the Licensed Product, with AstraZeneca’s support, provided however that:
a) Licensees shall notify AstraZeneca as early as reasonably practicable in advance of all meetings and significant communications with the Regulatory Authorities concerning the Licensed Product, but in any no later than five (5) business days;
b) Licensees shall forward to AstraZeneca electronic or physical copies of material written correspondence to and from Regulatory Authorities concerning the Licensed Product, promptly upon submission thereto or receipt therefrom, as applicable;
c) at AstraZeneca’s request, Licensees shall provide AstraZeneca with electronic or physical copies of Licensees’ material regulatory submission with respect to the Licensed Product; and
d) all activities to be conducted by Licensees pursuant to this Section 4.05 in connection with obtaining any emergency use authorizations or the equivalent as well as any Regulatory Approvals in the Territory shall be included in the Regulatory Plan.
4.06. Regulatory Filings Ownership
All regulatory filings and submissions made pursuant to this Article 4 shall be made in the name of, and be owned by, Licensees, [REDACTED].
4.07. Supply of Technology
Promptly after the Effective Date, AstraZeneca shall supply the Licensed Know-How required necessary for the Regulatory Activities of the Licensed Product and for the performance of the Purpose of this Agreement. Licensees shall obtain and make available such information, personnel, materials, services, facilities and other resources, and take such other actions, as are necessary or useful to enable AstraZeneca to supply such Know-How, as provided in Schedule D.