Master Alliance Provisions Guide (MAPGuide)

Fiocruz – AstraZeneca, COVID-19 Vaccine Technology Transfer Agreement

  • Intellectual Property | License Grants
  • Intellectual Property | Ownership of IP

2. Scope

Definitions

Licensed Technology” means, collectively, the Licensed Product, Licensed Know-How [definition redacted], Licensed Patents, Licensed Materials [definition redacted].

Licensed Patents” means all Brazilian patent applications and patents including, without limitation, any continuations, continuations-in-part and divisions of any such patents or patent applications, any patents issuing from any of the foregoing, any extensions or supplementary patent certificates thereto, in each case such patents or patent applications that may be necessary for the Regulatory Activity, Manufacture or Supply of the Licensed Product that are controlled by AstraZeneca or any of its Affiliates or which AstraZeneca has the right to sublicense under the Head License (as applicable) as of the Effective Date and during the Term of the Agreement. As of the Effective Date, the Licensed Patents are those that are set forth on Schedule A [schedule redacted]. Schedule A may be amended from time to time to include new additional Licensed Patents required for the Regulatory Activity, Manufacture or Supply of the Licensed Product, upon notice to Licensees within thirty (30) business days upon the filing of a patent application or the license of patents that are relevant in Territory by AstraZeneca, and by means of an amendment executed by the parties. Within two (2) Business Days as of the Effective Date, AstraZeneca shall provide Licensees with a list of all the patents and patent applications that cover or protect the Licensed Technology, as well as the full content of such documents, even if they are still under the secrecy period, that AstraZeneca or its licensors have filed for or intend to file for patent protection in Brazil.

2. Scope

2.0 The scope of this Agreement is the grant by AstraZeneca to Licensees of a sublicense or of the right to use the Licensed Know-How related to the manufacturing process of the IFA [API] of the Licensed Product, as well as the transfer of technology and know-how associated with the Licensed Know-How, in order to allow Licensees to obtain the required authorization, manufacture in their premises and Supply the Licensed Product in the Territory under this Agreement

2.01 Grant to Licensees

a) AstraZeneca grants to Licensees an exclusive license or sub-license, as applicable, exclusive, in the Territory under the Licensed Technology to Develop, make, use, offer, Supply, have Supplied, and import the Licensed Product in the Territory, including, without limitation, for the production of the active pharmaceutical ingredient (“IFA”) of the Licensed Product, subject to and in accordance with the provisions of this Agreement and the Head License (the “Sublicence”), solely for the Territory [REDACTED].

b) For the avoidance of doubt, the license set forth herein includes all Know-How and technology provided by AstraZeneca to the Licensees under the ETEC [Technological Order Agreement] and does not authorize Licensees to Exploit the Licensed Product outside the Territory. No sale to the private market is authorized or permitted, except as otherwise set forth under this Agreement.

c) Licensees shall not use and/or Exploit the Licensed Technology except as expressly authorized in this Agreement. Nothing in this Agreement shall limit or in any way restrict AstraZeneca and AstraZeneca’s Affiliates’ right to use and to grant licenses under the Licensed Technology for any purpose outside the Territory, except if otherwise set forth in this Agreement and for any product other than the Licensed Product (AZD1222).

2.02 Further Sublicensing

a) Licensees shall not be permitted to grant any further sublicences hereunder without the prior written consent of AstraZeneca, which consent shall be in AstraZeneca’s sole discretion.

b) Any further sublicense granted with AstraZeneca’s consent pursuant to this Section 2.02 shall be made pursuant to a sublicense agreement on terms and conditions consistent with this Agreement and the Head License (including Section 6 thereof), as each may be amended or otherwise modified from time to time, and Licensees shall remain fully responsible to AstraZeneca for the proper performance of such obligations and for all other acts and omissions of Licensees’ Sublicensees in relation to this Agreement as if it were an act or omission of Licensees.

[…]

2.04 Future Development

The scope of the Sublicense and Licensed Know-How granted hereunder does not include Future Developments developed by AstraZeneca or for which AstraZeneca has or acquires rights to exploit, license or sublicense. For purposes of this Agreement, “Future Developments” shall mean any addition of other viral antigens to the construct of the Licensed Product. In case there are new Future Developments, AstraZeneca shall promptly notify Fiocruz and grant Fiocruz a right of first refusal for negotiations involving the licensing of such Future Developments for the Brazilian public market to meet the needs of Brazilian Unified Health System (“SUS”), State and Municipal governments in Brazil, to be exercisable by Fiocruz within at most fifteen (15) days as of AstraZeneca’s notice. If within such fifteen (15)-day term, Fiocruz notifies AstraZeneca in writing of its intention to exercise its right of first refusal for negotiations, AstraZeneca shall, within at most thirty (30) days after Fiocruz’s notice, provide Fiocruz with a proposed term sheet outlining the main commercial and technical conditions for the licensing of such Future Developments, including price. Upon receipt of AstraZeneca’s proposed term sheet in good faith for a maximum term of one hundred and twenty (120) days. If the Parties are not able to conclude negotiations and sign the respective agreement within such one hundred and twenty (120) days, AstraZeneca shall be free to negotiate the licensing of such Future Developments in the Territory with one or more third parties.

2.05 Improvements

Improvements shall mean Licensed Product updates and/or modification of the sequence of the Licensed Product created after the Effective Date hereof, whether patentable or not, that are not “Future Developments”. Improvements shall be owned by the Party that create them, and the other Party shall be automatically granted a license over such Improvements developed during the term of this Agreement and while the respective patents remain valid, without the payment of any compensation (other than the compensation due under this Agreement). To the extent applicable, the license of Improvements shall be subject to the terms and conditions set forth under this Agreement, and the Party that receives the license from the owner of the Improvement shall bear any and all costs and expenses of implementing the production process of the cell bank and/or virus bank, if applicable. The Party that is the owner of the Improvements shall cooperate with the other Party in good faith to enable the other Party to negotiate and obtain from any third parties access to the materials that may be required for the exploitation of Improvements, including cells banks and/or virus bank, if applicable. In the event of any new Improvements, the developing Party must notify the other Party within thirty (30) days after the developing Party successfully completes the development of the Improvements.

5. Supply

[…]

5.07 AstraZeneca Option to Revoke Exclusivity

In case an audit, or administrative proceeding by the Regulatory Authority, or an audit by AstraZeneca uncovers a severe quality issue or an issue of regulatory compliance according to Applicable Laws by Licensees, which cannot be remedied within a term of sixty (60) days, AstraZeneca shall have the right, in its sole criteria upon written notice to Licensees, to revoke the exclusivity granted to Licensees under this Agreement. Upon such written notice, the license granted hereunder shall become non-exclusive, and AstraZeneca shall be allowed, in its sole criteria, to procure and appoint Unrelated Third Parties to manufacture and commercialize the Licensed Product in the Territory, or to manufacture and/or Supply and/or Commercialize the Products itself in the Territory. For the avoidance of doubt, any failure by Licensees to exercise its Best Efforts to obtain Regulatory Approval of the Licensed Product or otherwise Exploit the Licensed Product in the Territory would trigger the AstraZeneca options described in this Section 5.07.

5.08 Manufacturing Process Improvements

All manufacturing process improvements and all Know How derived from the manufacturing process will at all times be owned by Licensees.

9. Trademarks; Prosecution, Maintenance and Infringement of the Licensed Rights

9.01 Trademarks

a) Licensees will have the sole right to choose and decide on the Brazilian Common Denomination (“DCB”) trade names and trade dress used to Supply the Licensed Product in the Territory. The DCB shall be comprised in whole and part only of non-proprietary terms such as “Recombinant Covid-19 Vaccine”. Licensee shall not adopt any proprietary branding for the Licensed Product and will not adopt any name or trade dress elements or other branding similar to AstraZeneca’s trademarks and trade dress for its Covid-19 Vaccine product.

b) The Licensed Product shall not have a name which includes the word “Oxford”, “Ox”, or any variation thereto and, without AstraZeneca’s prior written approval, Licensees shall not register, or seek to register, any trademark for the Licensed Product which includes the world “Oxford”, “Ox”, “AstraZeneca”, “AZ” or any variation thereto; any/or include any reference to the Head Licensor, AstraZeneca or any other Affiliate of the Head Licensor or AstraZeneca on the Licensed Product or the packaging product inserts or sales and promotional material for the Licensed Product unless required by Applicable Law. For the avoidance of doubt, nothing in this Agreement (including the license granted to Licensees pursuant to Error! Reference source not found [sic].) shall serve to grant Licensees any license or other rights to use the name, logo, or trademark of AstraZeneca or any of its Affiliates (or any abbreviation or adaptation thereof) for any use whatsoever without the prior written approval of the said Party.

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.