Provision Language
Definitions
“Confidential Information” means all proprietary technical, commercial or other information, including trade secrets, processes, formulae, data, know–how, improvements, unpublished inventions, techniques, methods, marketing plans, strategies, customer lists and sales information, that are disclosed directly or indirectly by a Party or any of its Affiliates or agents to the other Party or any of its Affiliates or agents, as well as any other information and materials that are deemed confidential or proprietary to or by a Party or any of its Affiliates (including all information and materials of a Party’s (or its Affiliates’) customers and any other Third Party and their consultants), regardless of whether any of the foregoing are marked “confidential” or “proprietary” or communicated to the other by the disclosing Party in oral, written, graphic or electronic form. Confidential Information will include the Licensed Manufacturing Know-How.
4. TECHNICAL ASSISTANCE
4.1 Documentation and Assistance; Regulatory Filings in the Territory
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(b) The documentation provided by Shionogi (including the Regulatory Approvals) will not be used by GARDP or any of its Sublicensees for any purpose other than the Development, Manufacture and Commercialization of the Licensed Compound and Licensed Product in accordance with this License Agreement and the relevant Sublicense Agreement, and constitutes Confidential Information and trade secrets of Shionogi […].
8. INVENTIONS, PATENT MAINTENANCE, INFRINGEMENT
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8.2 Manufacturing Process Results
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(c) The Process Results shall be considered Confidential Information of the party who owns the results, provided in any case that each of Shionogi, GARDP and the Sublicensee that developed or generated the Process Results shall have the right to access and use all Process Results in accordance with the licenses set forth in Section 8.4.
10. NON DISCLOSURE OF CONFIDENTIAL INFORMATION
10.1 Non disclosure
(a) Each Party agrees that, for so long as this License Agreement is in effect and for a period of ten (10) years thereafter, or indefinitely with respect to all Confidential Information that constitutes trade secrets (including the Licensed ManufacturingKnow-How, including the content of the Technical Transfer Package, and the content of the Shionogi European Union and United States and all other cefiderocol regulatory filings, and any other Shionogi trade secrets, 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, a Party receiving Confidential Information of another Party (or that has received any such Confidential Information from such other Party prior to the Effective Date) will:
(i) maintain in confidence such Confidential Information using not less than the efforts such Party uses to maintain in confidence its own proprietary industrial information of similar kind and value;
(ii) not disclose such Confidential Information to any Third Party without the prior written consent of the relevant other Party, except for disclosure expressly permitted under this License Agreement; and
(iii) not use such Confidential Information for any purpose except those permitted by this License Agreement (it being understood that this Section (iii) will not create or imply any rights or licenses not expressly granted under Section 2 of this License Agreement).
(b) Exceptions
The obligations under Section 10.1(a) will not apply with respect to any portion of the Confidential Information that the receiving Party can show by written evidence:
(i) is or was publicly disclosed by the disclosing Party, either before or after it is disclosed to the receiving Party; or
(ii) 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
(iii) 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
(iv) is published by a Third Party or otherwise becomes publicly available, either before or after it is disclosed to the receiving Party; or
(v) has been independently developed by employees or contractors of the receiving Party or any of its Affiliates without the aid, application, or use of Confidential Information of the disclosing Party.
10.2 Authorized disclosure
(a) The receiving Party may disclose Confidential Information belonging to another Party to the extent (and only to the extent) such disclosure is reasonably necessary in the following instances:
(i) regulatory filings;
(ii) prosecuting or defending litigation;
(iii) 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 or regulations) and with judicial process, if in the reasonable opinion of the receiving Party’s counsel, such disclosure is necessary for such compliance; and
(iv) disclosure, in connection with the receiving Party’s performance of its obligations or exercise of its rights under this License Agreement and solely on a “need–to–know basis”, to Affiliates, potential Sublicensees and Sublicensees, potential donors and donors, research collaborators, employees, consultants, contractors, including GARDP Contractors, or agents, each of whom prior to disclosure must be bound by obligations of confidentiality and non–use at least 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 the Licensed Manufacturing Know-How, including the content of the Technical Transfer Package, and the content of the Shionogi European Union and United States and all other cefiderocol regulatory filings, and any other Shionogi trade secrets, 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.
(b) 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 License 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.
14. MISCELLANEOUS
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14.7 Publicity
The Parties agree that neither Party will issue a press release or public announcement concerning the transactions contemplated by this License Agreement without the prior written consent of the other Parties. If either Party intends to issue a press release, it will submit a draft of such proposed press release to the other Parties 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 Parties 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 License Agreement, the identity of the Parties, and the terms, conditions, and subject matter previously disclosed about the License Agreement, provided such disclosures or statements are accurate and complete with respect to the subject matter thereof and the information disclosed therein. The Parties agree and acknowledge that nothing in this Section shall restrict the press releases or public announcements of any third party based on publicly available information.
Schedule F: Provisions for Sublicense Agreement
6. Intellectual Property
Manufacturing Process Results
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(c) The Process Results shall be considered confidential information of the party who owns the results, provided that each of Licensor, Sublicensor and 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 License Agreement.
17. Confidentiality and Non–Disclosure
17.1 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 Licensed Manufacturing Know-How, including the content of the Technical Transfer Package, and the content of the Licensor’s European Union and United States cefiderocol regulatory filings received or accessed by Sublicensee, and any other trade secrets of the Licensor, 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 Agreement or such use is reasonably necessary for the performance of its obligations or the exercise of its rights under this 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 Agreement, including the terms of this 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 Licensed Rights [(including the Licensed Manufacturing Know-How) – IF APPLICABLE], 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 17.1 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.
17.2 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:
(i) regulatory filings;
(ii) prosecuting or defending litigation;
(iii) 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
(iv) disclosure, in connection the receiving Party’s performance of its obligations or exercise of its rights under this Agreement and solely on a “need–to–know 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 17 (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 Licensed Manufacturing Know-How, including the content of the Technical Transfer Package, and the content of Licensor’s European Union and United States cefiderocol regulatory filings received or accessed by Sublicensee, and any other trade secrets of the Licensor, 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 17.
If and whenever any Confidential Information is disclosed in accordance with this Section 17.2, 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 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 17.2 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.
17.3 Destruction of Confidential Information. Within sixty (60) Business Days after termination or expiration of this 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 17.3; 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 Licensed Manufacturing Know-How, including the content of the Technical Transfer Package, and the content of Licensor’s European Union and United States cefiderocol regulatory filings received or accessed by Sublicensee, and any other trade secrets of the Licensor, 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 a 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 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 17 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, Sublicensees are prohibited from retaining any Confidential Information received by the Sublicensee that constitutes trade secrets, including, without limitation, the Licensed Manufacturing Know-How, including the content of the Technical Transfer Package, and the content of Licensor’s European Union and United States cefiderocol regulatory filings received or accessed by Sublicensee, and any other trade secrets of the Licensor, 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 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 17 above.