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.
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.
[“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.]