Provision Language
8. INTELLECTUAL PROPERTY, PATENT MAINTENANCE, INFRINGEMENT
8.1 Intellectual property. […]
(a) Manufacturing Process Results […]
(ii) The Process Results shall be considered confidential information of the party who owns the results, provided that each of Shionogi, GARDP and the Sublicensee shall have the right to access and use all Process Results in accordance with the licenses set forth in this Sublicense Agreement and the Shionogi License Agreement.
10. CONFIDENTIALITY AND NON-DISCLOSURE
10.1 Confidentiality Obligations
At all times during the Term and for a period of ten (10) years following termination or expiration of this Sublicense Agreement, or indefinitely with respect to all Confidential Information that constitutes trade secrets (including, without limitation, any Sublicensed Manufacturing Know-How, including the content of the Technical Transfer Package, and the content of Shionogi’s European Union and United States cefiderocol regulatory filings received or accessed by the Sublicensee, and any other trade secrets of Shionogi, including all Confidential Information that is of a technical nature, is identifiable and substantial, and has commercial value because it is not publicly available), for so long as the relevant trade secrets do not become publicly available other than as a result of a fault attributable to the receiving Party or its agents or sublicensees, each Party shall, and shall cause its Affiliates and their respective officers, directors, employees and agents to, keep completely confidential and not publish or otherwise disclose to a Third Party and not to use, directly or indirectly, for any purpose, any Confidential Information furnished or otherwise made known to it, directly or indirectly, by the other Party, except to the extent such disclosure or use is expressly permitted by the terms of this Sublicense Agreement or such use is reasonably necessary for the performance of its obligations or the exercise of its rights under this Sublicense Agreement. “Confidential Information” means any information provided by one Party (the “Disclosing Party”) to the other Party (the “Receiving Party”) under or in connection with this Sublicense Agreement, including the terms of this Sublicense Agreement or any information relating to the Licensed Product (including the regulatory documentation and market approvals and any information or data contained therein), any information relating to any exploitation of the Licensed Product in the Territory or the scientific, regulatory or business affairs or other activities of either Party. For the purposes hereof, the Sublicensed Rights (including the Sublicensed Manufacturing Know-How), shall be deemed to be Confidential Information of GARDP, and the terms of this Sublicense Agreement shall be deemed Confidential Information of both Parties. The obligations under Section 10.1 will not apply with respect to any portion of the Confidential Information that the Receiving Party can show by written evidence:
(a) is or was publicly disclosed by the Disclosing Party, either before or after it is disclosed to the Receiving Party; or
(b) was known to the Receiving Party or any of its Affiliates, without any obligations to keep it confidential or any restriction on its use, prior to disclosure by the Disclosing Party; or
(c) is subsequently disclosed to the Receiving Party or any of its Affiliates by a Third Party lawfully in the possession thereof and without any obligation to keep it confidential or any restriction on its use; or
(d) is published by a Third Party or otherwise becomes publicly available, either before or after it is disclosed to the Receiving Party; or
(e) has been independently developed by employees or contractors of the Receiving Party without the aid, application, or use of Confidential Information of the Disclosing Party.
Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the Receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the Receiving Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the Receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the Receiving Party unless the combination and its principles are in the public domain or in the possession of the Receiving Party.
10.2 Authorized Disclosures
Each Receiving Party may disclose Confidential Information disclosed to it by the Disclosing Party to the extent (and only to the extent) that such disclosure by the Receiving Party is reasonably necessary in the following instances:
(a) regulatory filings;
(b) prosecuting or defending litigation;
(c) complying with applicable governmental laws and regulations (including the rules and regulations of the Securities and Exchange Commission or any national securities exchange or laws and regulations) and with judicial process, if in the reasonable opinion of the Receiving Party’s counsel, such disclosure is necessary for such compliance; and
(d) disclosure, in connection the receiving Party’s performance of its obligations or exercise of its rights under this Sublicense Agreement and solely on a “need-toknow basis”, to Affiliates, potential sub-sublicensees and sub-sublicensees, potential donors and donors, research collaborators, employees, consultants, contractors or agents, each of whom prior to disclosure must be bound by obligations of confidentiality and non-use substantially equivalent in scope to those set forth in this Section 10 (the duration of such obligations being at least for the duration of the agreement with such other Person and a period of ten (10) years thereafter, or indefinitely with respect to all Confidential Information that constitutes trade secrets (including, without limitation, any Sublicensed Manufacturing Know-How, including the content of the Technical Transfer Package, and the content of Shionogi’s European Union and United States cefiderocol regulatory filings received or accessed by the Sublicensee, and any other trade secrets of Shionogi, including all Confidential Information that is of a technical nature, is identifiable and substantial, and has commercial value because it is not publicly available), for so long as the relevant trade secrets do not become publicly available other than as a result of a fault attributable to the receiving Party or to such other Person; provided, however, that the Receiving Party will remain responsible for any failure by any such Person who receives Confidential Information to treat such Confidential Information as required under this Section 10.
(e) If and whenever any Confidential Information is disclosed in accordance with this Section 10.2, such disclosure will not cause any such information to cease to be Confidential Information except to the extent that such disclosure results in a public disclosure of such information (otherwise than by breach of this Sublicense Agreement). Where reasonably possible, the receiving Party will notify the disclosing Party of the receiving Party’s intent to make such disclosure pursuant to this Section 10.2 sufficiently prior to making such disclosure so as to allow the disclosing Party adequate time to take whatever action it may deem appropriate to protect the confidentiality of the information.
10.3 Destruction of Confidential Information. Within sixty (60) Business Days after termination or expiration of this Sublicense Agreement, each Party shall at the other Party’s request: (A) return to the other Party or destroy all documents and tangible materials (and any copies) containing Confidential Information of the other Party; and (B) certify to the other Party in writing that it has complied with the requirements of this Section 10.3; provided that: (i) the Receiving Party may retain one archival copy of the Confidential Information of the other Party, but not any Confidential Information that constitutes trade secrets of the other Party (including, without limitation, the Sublicensed Manufacturing Know-How, including the content of the Technical Transfer Package, and the content of Shionogi’s European Union and United States cefiderocol regulatory filings received or accessed by the Sublicensee, and any other trade secrets of the Shionogi, including all Confidential Information that is of a technical nature, is identifiable and substantial, and has commercial value because it is not publicly available, except for any of such that has become publicly available other than as a result of a fault attributable to GARDP and/or the Sublicensee) in a limited access file (meaning only accessible by such Party’s Information Technology (IT) department or by such Party’s legal personnel) to the extent that the receiving Party requires such Confidential Information for the purpose of performing any obligations or exercising any rights under this Sublicense Agreement that may survive such expiration or termination, subject in any case to continued compliance by such Party of its confidentiality obligations as set out in section 10 above; (ii) the receiving Party may retain Confidential Information of the other Party to the extent that the receiving Party is required to retain such information for compliance purposes under applicable laws and regulations; and (iii) the above obligations shall not require either Party to delete any automatic electronic backup files maintained in accordance with its standard policies and to which access is limited and only accessible by such Party’s IT department. Notwithstanding any of the foregoing, the Sublicensee is prohibited from retaining any Confidential Information received by the Sublicensee that constitutes trade secrets, including, without limitation, the Sublicensed Manufacturing Know-How, including the content of the Technical Transfer Package, and the content of Shionogi’s European Union and United States cefiderocol regulatory filings received or accessed by the Sublicensee, and any other trade secrets of Shionogi, including all Confidential Information that is of a technical nature, is identifiable and substantial, and has commercial value because it is not publicly available, except for any of such that has become publicly available other than as a result of a fault attributable to the Sublicensee or its agents or sublicensees and except as may be required for compliance purposes under applicable laws and regulations, and subject in any case to continued compliance by such Party of its confidentiality obligations as set out in Section 10 above.
14. MISCELLANEOUS
14.9 Publicity. The Parties agree that no Party will issue a press release or public announcement concerning the transactions contemplated by this Sublicense Agreement without the advance written consent of the other Party. If a Party intends to issue a press release, it will submit a draft of such proposed press release to the other Party at least five (5) Business Days prior to the date such Party intends to issue the release and will agree to consider the comments of the other Party to the press release. After any initial press release or public announcement is made, however, each Party may disclose to Third Parties or make public statements, by press release or otherwise, regarding the existence of this Sublicense Agreement, the identity of the Parties, and terms, conditions and subject matter previously disclosed about the Sublicense Agreement, provided such disclosures or statements are accurate and complete with respect to the subject matter thereof and the information disclosed therein.