11. Term and Termination
11.03 Termination by Licensees
Licensees shall be entitled to terminate this Agreement in its entirety by giving AstraZeneca immediate written notice of termination:
a) If AstraZeneca commits a material breach of its obligations in this Agreement and, having been notified of such material breach, fails to remedy it within ninety (90) days of notification.
b) In the situations provided for in items I to XII, XVII and XVIII of art. 78 Law No. 8.666, dated 1993, and with the consequences indicated in art. 80 of the same Law, without prejudice to the application of any applicable sanctions.
c) In the event AstraZeneca, without cause, delays or interrupts the performance of its obligations provided for in the Supply of Technology Work Plan;
d) If, during the Term, for any reason not provided above, the Ministry of Health chooses to discontinue orders and/or use of the Licensed Product in the Territory;
e) In the event of a change of control in AstraZeneca which materially or adversely affects Licensee’s interest and the Parties are not able to reach a positive solution within a reasonable period;
f) in case the Licensed Product provenly causes severe adverse reactions that may make the Licensed Product unsafe in the Territory and the Parties are not able to agree on a technical solution to overcome the reasons behind such reactions. In this case, the costs associated with the research and activities required for the solution of the aforementioned adverse reactions will be borne by AstraZeneca. For clarity, the Parties acknowledge that AstraZeneca will only be held responsible for the above–mentioned costs with research and activities for solution of the severe adverse reactions due to events proven and direct related to the Vaccine Product, and not something that have happened at Licensees’ Exploitation process that is not in accordance with the express instructions from AstraZeneca or with this Agreement;
g) In the event of a proven issue or safety of efficacy in connection with the Licensed Product not covered by Section 11.03(f) but which, in the reasonable opinion of one of the Parties, renders it impossible to obtain Regulatory Approval for the Licensed Product or results in a suspension of the existing registration; or
h) If the other Party fails to comply with anti–corruption and anti–bribery obligations provided for in the applicable laws.
11.04 Termination by AstraZeneca
a) AstraZeneca shall be entitled to terminate this Agreement partially or in its entirety by giving Licensees immediate written notice of termination if Licensees commits a material breag of its obligations in the Agreement, and, having been notified of such material breach, fails to remedy it within ninety (90) days of notification, and such term may be extended at AstraZeneca’s sole discretion in case it is justified and Licensees present a robust and reasonable plan to remedy the default.
b) AstraZeneca shall be entitled to terminate this Agreement if Bio–Manguinhos does not prepare its facilities properly to receive the Technology as required by this Agreement or for some other reason is unable to absorb the technology to be transferred, provided that in both cases that does not happen for exclusive fault of AstraZeneca; or the Licensees fail to produce the Licensed Product in an amount sufficient to attend the needs of the Territory; having been notified of such material breach, fails to remedy it within (30) days of notification.
c) AstraZeneca shall be entitled to terminate this Agreement forthwith by giving Licensees written notice of immediate termination if:
(i) Licensees fail to pay the Sublicense Fee, Additional Fee or any other fee or payment due under this Agreement within forty–five (45) days after the original payment due date;
(iv) Licensees breach the product security and/or quality requirements of this Agreement and/or have significant quality issues, provided that Licensees are notified of such occurrences and the Parties are not able to agree on a technical solution in thirty (30) days to overcome the reasons behind such issues;
(v) If any of the Licensees fail to comply with anti–corruption and anti–bribery obligations provided for in the applicable laws; and/or
(vi) In any of the Licensees is acquired or incorporated into private companies.
11.05 Mutual termination
The Parties can terminate this Contract by a mutual agreement:
a) in accordance with article 79, caput II of Law 8,666/1993; and/or
b) in the event there is a significant safety or efficacy issue with the Licensed Product such that it could jeopardize or risk the Regulatory Approval in that regard, provided that Licensees are notified of such occurrences and the Parties are not able to agree on a technical solution to overcome the reasons behind such issues.
11.06 In case of unforeseeable facts or facts that although predictable have consequences that are impossible to be foreseen that materially affect the financial and economic balance of this Agreement, the Parties shall discuss in a good faith the reasonably necessary measures and amendments to this Agreement with the purpose of restoring the balance that existed on the Effective Date between the obligations of the Parties and the respective compensation due to AstraZeneca for the fair remuneration of the scope of this Agreement.