Master Alliance Provisions Guide (MAPGuide)

Fiocruz – AstraZeneca, COVID-19 Vaccine Technology Transfer Agreement

  • Information & materials sharing | Confidentiality

8. Confidentiality
8.01. Definition of Confidential Material
In this Agreement, “Confidential Material” shall subject to Section 8.02, mean:
a) any and all Know-How, software, algorithms, designs, plans, forecasts, analyses, evaluations, research, business information, financial information, business plans, strategies, customer lists, marketing plans, or other information whether oral, in writing, in electronic form, or in any other form; and
b) any physical items, compounds, components, samples of other materials; disclosed by or on behalf or a Party (which, in the case of AstraZeneca, includes the Head Licensor), any of that Party’s Affiliates (the “Disclosing Party”) to the other Party or any of the other Party’s Affiliates (the “Receiving Party”) before, on or after the Effective Date. For the avoidance of doubt, as between the Parties, the Licensed Know-How, Licensed Materials and any Confidential Material disclosed by or on behalf of the Head Licensor to Licensees in furtherance of the Objectives are the Confidential Material of AstraZeneca. All data and information first disclosed by Licensees to AstraZeneca and or its affiliates and or the Head Licensor with respect to the Regulatory Activity, Manufacturing and Supply of the Licensed Product by Licensees shall be the Confidential Material of Licensees.

8.02. Exclusions from Confidential Material
In this Agreement, Confidential Material shall not include any information or materials which the Receiving Party can prove:
a) is or becomes public knowledge through no improper conduct on the part of the Receiving Party, the Receiving Party’s Affiliates and/or their respective Personnel;
b) is already lawfully possessed by the Receiving Party and/or the Receiving Party’s Affiliates without any obligations of confidentiality or restrictions on use prior to first receiving it from the Disclosing Party; and/or
c) is obtained subsequently by the Receiving Party and/or the Receiving Party’s Affiliates from a Unrelated Third Party without any obligations of confidentiality and such Unrelated Third Party is in lawful possession of such information or materials and not in violation of any contractual or legal obligation to maintain the confidentiality of such information or materials.

8.03. Limitations on Use of Confidential Material
The Receiving Party shall treat all Confidential Material as secret and confidential and shall not use, copy or disclose to any third party any Confidential Material of the Disclosing Party (whether before, on or after the date of this Agreement) expect as set out in Section 8.04 below.

8.04. Uses and Disclosures of Confidential Material
The Receiving Party may:
a) use and disclose Confidential Material of the Disclosing Party to the extent necessary to enable the Receiving Party to exploit the rights granted under this Agreement including for the purposes of applying for Regulatory Approval or Product Approval or a patent for the Licensed Product provided that where such disclosure is to third parties (other than in connection with an application for Regulatory Approval or Product Approval or a patent for the Licensed Product) the Receiving Party shall: (1) only disclose Confidential Material to third parties that have entered into appropriate and legally binding confidentiality and non-use obligations in respect of the Confidential Material disclosed; and (2) procure that such third parties do not further disclose or use Confidential Material

b) disclose Confidential Material of the Disclosing Party to those of the Receiving Party’s Affiliates, officers and employees to whom such discretion is necessary (and only disclose that part of the Confidential Material which is necessary) to enable the Receiving Party to exploit the rights granted under this Agreement and/or to perform its obligations under this Agreement and provided that, subject to Section 8.04(e), the Receiving Party shall remain responsible for procuring that the Receiving Party’s Affiliates, officers and employees do not further disclose and/or use the Confidential Material for any other purpose;

c) In the case of AstraZeneca, with Licensees’ prior written consent (which shall not be unreasonably withheld, conditioned or delayed), disclose Confidential Material of Licensees’ to the Head Licensor which shall be entitled to use and disclose such Confidential Material on the same terms as AstraZeneca under this Agreement;

d) after giving written notice to the Disclosing Party, disclose any part of the Confidential Material solely to the extent that it is legally required to do so pursuant to an order of a court of competent jurisdiction or other Governmental Authority or otherwise as required by Applicable Law including the laws and regulations applying to any public listing authority, provided that the Receiving Party shall use reasonable endeavors to limit such disclosure and to provide the Disclosing Party with an opportunity to make representations to the relevant court or other Governmental Authority, Regulatory Authority, or allied authority or listing authority; and

e) disclose any information concerning this Agreement and/or the development of the Licensed Product with the Brazilian Government or Her Majesty’s Government, including sharing the terms of this Agreement.

8.05. Related Rights
All documents, materials and other items (including items in electronic form), and any Intellectual Property Rights therein, provided by or on behalf of the Disclosing Party to the Receiving Party containing Confidential Material shall remain the absolute property of the Disclosing Party. Other than as expressly set forth herein, nothing in this Agreement shall be construed (by implication, estoppel or otherwise) as granting, or as an undertaking by the Disclosing Party or any of its personnel to subsequently grant, to the Receiving Party any license, right, title or interest in or to the Disclosing Party’s Confidential Material or to any present or future patent, patent application, know-how, copyright, trademark, trade secret or other proprietary right. Nothing in this Agreement shall be construed to prevent the Disclosing Party from using in any manner its own Confidential Material or disclosing in any way to third parties its Confidential Material.

8.06. Protection of Confidential Material
The Receiving Party shall at all times maintain documents, materials and other items (including items in electronic form) containing Confidential Material of the Disclosing Party and any copies thereof, in a secure fashion by taking reasonable measures to protect them from theft and unauthorized use and disclosure. Without prejudice to the foregoing, the Receiving Party shall exercise at least the same degree of care to prevent theft and unauthorized disclosure and/or use of the Disclosing Party’s Confidential Material as the Receiving Party exercises in respect of its own confidential material of like importance.

8.07. Losses of Confidential Material
The Receiving Party shall notify the Disclosing Party immediately if the Receiving Party becomes aware of any unauthorized use or disclosure of, or any unauthorized access to or of any theft or loss of any copies of any Confidential Material of the Disclosing Party.

9. Trademarks; Prosecution, Maintenance and Infringement of the Licensed Rights
9.01 Trademarks
[…]
c) The Parties agree not to use any names, trademarks, registered or not, logos, symbols, or other designations of the other Party or its employees, especially, but not limiting, in any advertising, press information or publicity, without prior written approval of the said Party.

15. General
15.09. Publicity & Non-Disclosure
a) Upon execution of this Agreement, the Parties shall agree the content and timing for a joint public press release.

b) If either Party wishes to make any formal press release regarding the development of any the Licensed Product or the terms and conditions of this Agreement, during the term of this Agreement, the Parties shall, acting reasonably and in good faith, agree the terms of the formal press release.

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d) Neither Party shall disclose any information concerning this Agreement (including its provisions, or disputes relating to it) to any third party provided that:

(i) A Party may disclose the information concerning this Agreement:

1) To its legal advisers, auditors and/or regulators;

2) As necessary to enforce this Agreement; and/or

3) To a third party (including the professional advisers or such third party) that intends to acquire substantially all of the relevant business of that Party or to a potential sublicensee on condition that such third party has executed a legally binding confidentiality agreement under which it agrees:
Not to further disclose the provisions of this Agreement except to its professional advisers who are legally bound by appropriate confidentiality and non-use-obligations in respect of this Agreement; and
Not to use knowledge of the provisions of this Agreement except for the purpose of evaluating whether or not to acquire the relevant business of that party or enter into a sublicence.

(ii) either party shall be entitled to disclose any information concerning this Agreement, the collaboration hereunder and/or the development of the Licensed Product with the Brazilian Government or Her Majesty’s Government or other governmental bodies and institutions, including sharing the terms of this Agreement.

(iii) The Parties shall use reasonable endeavors to ensure that, to the extent permitted by relevant authorities and by Applicable Laws, this Agreement shall not form party of any disclosure to the public without the proper protections of Confidential Materials. The Parties acknowledge that the Licensees are bound to transparency rules related to the Law No. 12.527/2011 (Information Access Statute, and applicable regulation) (“IAS”). Therefore, within 5 business days from the Effective Date, the Parties will determine which provisions of this Agreement contain confidential information or Confidential Materials, and the appropriate justification, under the requirements of the IAS. After the proper processing, the remaining terms of this Agreement which do not contain confidential information or Confidential Materials will be published at Licensee’s transparency portals.

(iv) If a Party is required by law of the rules of a stock market upon which it of its Affiliates stocks or shares are traded to make any disclosure concerning this Agreement then such disclosure may be made on condition that:
the Party making the disclosure shall, if permissible under the said laws or rules, notify the other Party of the full text of the disclosure as soon as possible prior to its release so that the other Party shall have an opportunity to comment upon the disclosure and in any event, the Party of the full text of the disclosure as issued promptly after making the disclosure;
if a Party makes a disclosure pursuant to this Section 15.09(d)(iv), the other Party shall have the right to issue its own disclosure in response and shall notify the Party that made the original disclosure with the full text of the disclosure in response as issued, promptly after issuing the disclosure in response; and
any disclosure made pursuant to this Section 15.09(d)(iv) shall be factual and as brief as possible and limited to this Agreement only.

15.17. Publication in the Official Gazette
This Agreement will be published by the Licensees in the form of an extract in the Official Gazette of the Federal Union, until the fifth business day of the month following that of its signature, to occur within twenty (20) days of that date (art. 61, sole paragraph, of Law No. 8,666, 1993).