ANVISA Transition Letter for Legal Compliance

ANVISA Transition Letter for Legal Compliance

This ANVISA Transition Letter for Legal Compliance (the "Letter") is made and entered into as of Effective Date: by and between Transferor Name: , Corporate/Tax ID: , and Transferee Name: , Corporate/Tax ID: (each a "Party" and collectively the "Parties").

RECITALS

WHEREAS, Transferor is the current holder of regulatory submissions, registrations, dossiers, and other compliance obligations required under the applicable sanitary regulations administered by the National Health Regulatory Authority and holds responsibility for ensuring continued regulatory compliance in relation to the Products described in Appendix A; and

WHEREAS, Transferee has requested and Transferor has agreed to transfer specified regulatory responsibilities and associated records to Transferee in order to effectuate an orderly transition of regulatory accountability for the Products and to ensure ongoing compliance with applicable regulatory requirements; and

WHEREAS, the Parties wish to set forth the terms and conditions under which the transfer of legal and administrative responsibilities relating to ANVISA matters will occur.

NOW, THEREFORE

In consideration of the mutual covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

1. DEFINITIONS

1.1 "ANVISA Matters" means all regulatory filings, registrations, licences, dossiers, pharmacovigilance obligations, safety reports, correspondence with regulatory authorities, and related records that are required to comply with applicable sanitary laws and regulations concerning the Products identified in Appendix A.

1.2 "Effective Date" means the date set forth above and, for the purposes of liabilities and obligations, the date on which the transfer of responsibilities becomes operative as provided in Section 3.

2. SCOPE OF TRANSFER

2.1 Transferor agrees to transfer to Transferee, and Transferee agrees to accept, the ANVISA Matters specified in Appendix A and the records described in the Records Schedule. The transfer shall include all documents, submissions, safety data, and procedural histories reasonably necessary to enable Transferee to assume regulatory responsibility.

2.2 The Parties acknowledge that any regulatory authority approvals required to reflect the transfer of holder or responsible party shall be pursued in accordance with applicable rules, and each Party shall reasonably cooperate to obtain such approvals.

3. EFFECTIVE DATE AND TRANSITION PERIOD

3.1 The transfer of responsibilities pursuant to this Letter shall become effective on the Effective Date. Transferor shall continue to perform obligations arising prior to the Effective Date, except as expressly transferred herein.

3.2 The Parties agree to a transition period of days from the Effective Date (the "Transition Period") during which Transferor shall provide reasonable assistance to Transferee, including knowledge transfer, document delivery, and cooperation with regulatory correspondence.

4. DELIVERY OF RECORDS

4.1 Transferor shall deliver to Transferee, no later than days after the Effective Date, all physical and electronic records necessary for Transferee to assume regulatory responsibilities, in the formats reasonably requested by Transferee.

4.2 Transferor warrants that the records delivered are complete and, to the best of Transferor's knowledge, accurate and not misleading in any material respect as of the Effective Date.

5. NOTIFICATIONS TO AUTHORITIES

5.1 Each Party shall take commercially reasonable steps to notify regulatory authorities, including ANVISA where applicable, of the change in responsible party or holder as required by law. The Party formally responsible for such notification shall be indicated in the Notices section below.

6. REPRESENTATIONS AND WARRANTIES

6.1 Transferor represents and warrants that: (a) it has full power and authority to effect the transfer described herein; (b) with respect to the Records being transferred, there are no known unresolved violations or pending administrative sanctions that have not been disclosed in writing to Transferee; and (c) it has not withheld any material information relevant to the ANVISA Matters.

6.2 Transferee represents and warrants that it has the organizational capacity, appropriate registrations, and internal systems to undertake the compliance obligations as of the Effective Date and will use commercially reasonable efforts to maintain compliance thereafter.

7. INDEMNIFICATION

7.1 Transferor shall indemnify, defend and hold harmless Transferee and its affiliates from and against any and all losses, liabilities, costs, fines, penalties and expenses (including reasonable attorneys' fees and costs of defense) arising out of or resulting from any breach of Transferor's representations and warranties, or any noncompliance with applicable sanitary regulations occurring prior to the Effective Date.

7.2 Transferee shall indemnify, defend and hold harmless Transferor from and against any and all losses, liabilities, costs, fines, penalties and expenses arising out of Transferee's failure to perform obligations assumed under this Letter after the Effective Date.

8. CONFIDENTIALITY

8.1 Each Party shall maintain in confidence all non-public information received from the other Party in connection with the transition, including regulatory dossiers, safety data and correspondence with authorities, and shall not disclose such information except as required by law, regulatory process, or with the prior written consent of the disclosing Party.

9. RECORDS RETENTION

9.1 Each Party shall retain copies of the records relevant to ANVISA Matters for a period consistent with applicable regulatory retention requirements. Transferor will retain or provide copies of archived records for a period of years from the Effective Date unless otherwise required by law.

10. NOTICES

All notices, requests, consents and other communications required or permitted under this Letter shall be in writing and delivered to the addresses set forth below.

11. AMENDMENTS, WAIVER, COUNTERPARTS

11.1 No amendment or modification of this Letter shall be effective unless in writing and signed by duly authorized representatives of both Parties.

11.2 No failure or delay by either Party in exercising any right under this Letter shall operate as a waiver of that right. Any waiver must be in writing and signed by the waiving Party.

11.3 This Letter may be executed in counterparts, each of which shall be an original and all of which together shall constitute one and the same instrument.

12. GOVERNING LAW, ENTIRE AGREEMENT, SEVERABILITY

12.1 Governing Law. This Letter shall be governed by and construed in accordance with the laws of the Federative Republic of Brazil without regard to conflict of law principles.

12.2 Entire Agreement. This Letter, including any appendices and schedules referenced herein, constitutes the entire agreement between the Parties with respect to the subject matter hereof and supersedes all prior agreements and understandings, whether written or oral, relating thereto.

12.3 Severability. If any provision of this Letter is held invalid or unenforceable by a court of competent jurisdiction, the remaining provisions shall remain in full force and effect and the Parties shall negotiate in good faith to replace the invalid or unenforceable provision with a valid and enforceable provision that achieves, to the extent possible, the Parties' original intent.

MISCELLANEOUS PROVISIONS

13.1 Assignment. Neither Party may assign its rights or delegate its duties under this Letter without the prior written consent of the other Party, except that Transferee may assign to an affiliate or successor in connection with a merger or sale of substantially all of its assets provided that the assignee assumes Transferee's obligations hereunder.

13.2 Cooperation with Regulatory Inquiries. After the Effective Date, the Parties shall cooperate reasonably and in good faith with one another in connection with any inquiries, inspections, audits or proceedings by regulatory authorities relating to matters occurring prior to the Effective Date.

APPENDIX A: PRODUCTS SUBJECT TO TRANSFER

List products, registrations and identifiers below or attach a separate schedule. If attached, indicate attachment here: Attached

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