Provision Language
2. LICENSE GRANTS
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2.3 Sublicenses
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(g) GARDP will procure that: […]
(ii) each applicable Sublicensee will file for registration of the Licensed Product in at least one country in the Territory within four (4) years of the start of technical transfer pursuant to Section 4.2 to the Sublicensee, or if there is no technical transfer to the Sublicensee, within four (4) years of the Effective Date of the applicable Sublicense Agreement.
4. TECHNICAL ASSISTANCE
4.1 Documentation and Assistance; Regulatory Filings in the Territory
(a) Upon GARDP’s request, Shionogi will provide GARDP or its Sublicensees, as applicable, with access to the content of the regulatory filings included within the Licensed Rights and described on Exhibit D (collectively, the Regulatory Approvals) to the extent reasonably required for the Manufacture or Commercialization of Licensed Product(s) in one or more countries in the Territory, all for use in accordance with the license granted pursuant to this License Agreement. Upon GARDP’s request, Shionogi will also provide GARDP or its Sublicensees, as applicable, with regulatory filing reference rights (including promptly providing to GARDP or its Sublicensees or any relevant Regulatory Authorities any letters of authorization or comparable documents that may be required) pursuant to which the applicable Regulatory Authority could access the content of the Regulatory Approvals and regulatory exclusivity waivers (i.e. waivers of any rights Shionogi or its Affiliates may have under any applicable regulatory or data exclusivity regulations that would prevent GARDP or its Sublicensees from Commercializing Licensed Product in any country(ies) in the Territory, or using or referencing the Regulatory Approvals for such purpose, all in accordance with the license granted pursuant to this License Agreement), in each case to the extent reasonably required by the applicable Regulatory Authorities for the Manufacture, or Commercialization of Licensed Product(s) in the Territory.
(c) Shionogi will be responsible for providing one set of electronic copies only, subject to Section 4.1(a). Shionogi will respond to reasonable requests from GARDP or its Sublicensees for clarification on the documents and information provided under this Section 4.1, where responses to such requests are reasonably necessary to clarify the Manufacture and registration (in the manner Manufactured by or for Shionogi and registered by Shionogi on the Effective Date) of the Licensed Compound or a Licensed Product.
(d) Notwithstanding the foregoing, Shionogi does not represent any Licensed Product is equivalent to any product containing cefiderocol (including but not limited to cefiderocol sulfate tosylate) which is Manufactured or sold by Shionogi, and no regulatory exclusivity waiver granted by Shionogi shall be understood to make any such representation.
(e) Shionogi shall have the right to review and comment on the content of all preclinical and clinical data portions of all regulatory filings for the approval of the Licensed Product in the Territory as well as all proposed product labels, package inserts and Company Core Data Sheets (CCDS) (including a list prepared by GARDP and/or the relevant Sublicensee of deviations between the proposed CCDS and the then–existing CCDS of Shionogi) proposed to be submitted to Regulatory Authorities for the Licensed Product in the Territory. Copies of all such documents shall be provided to Shionogi in English. Shionogi shall have the right to oppose any proposed regulatory filing in the Territory for failure to comply with the foregoing requirements, or based on reasonable concerns relating to the accuracy and quality of the data included therein, and the proposed filing may not proceed until Shionogi’s opposition has been resolved as set forth herein. Any disagreement regarding proposed regulatory filings contemplated by this Section shall be escalated for resolution to the Joint Steering Committee (JSC) formed pursuant to the Collaboration Agreement; a representative of the Sublicensee will be invited to the JSC if the Parties deem appropriate. Shionogi shall use reasonable best efforts to provide feedback to any such documents submitted to Shionogi for review within thirty (30) days.
(f) Shionogi shall not be responsible for the performance of additional studies or submission of additional data for the grant of the regulatory approval of a Licensed Product in the Territory. Sublicensees shall agree not to seek any further regulatory exclusivity in the country(ies) governed by their Sublicense Agreement.
6. PHARMACOVIGILANCE AND QUALITY MATTERS
6.1 Pharmacovigilance
(a) GARDP will require that its Sublicensees, in accordance with their standard protocols, maintain effective and reliable systems for receiving and tabulating any reports of adverse reactions to the Licensed Product and to report such information on a timely basis to the relevant Regulatory Authorities in the countries of the Territory included in their respective Sublicenses in accordance with local laws and regulations. GARDP will require that its Sublicensees be responsible for fulfilling all required pharmacovigilance reporting responsibilities under applicable laws and regulations within the countries in the Territory included in their respective Sublicenses. The responsibilities of the Parties and of the Sublicensees for safety related or Licensed Product related inquiries will be performed in accordance with applicable local laws and regulations. Shionogi will be responsible for maintaining the global pharmacovigilance database for the Licensed Product, and GARDP shall: (i) cause each Sublicensee to enter into a safety data exchange agreement (SDEA) with Shionogi and GARDP on terms reasonably acceptable to Shionogi and based on a first draft proposed by Shionogi, governing the exchange of Licensed Product safety information among Sublicensee, Shionogi and GARDP that is consistent with applicable regulations and global pharmacovigilance standards; and (ii) use reasonable best efforts to monitor the activities and duties of the Sublicensees to ensure the Sublicensees’ compliance with their respective pharmacovigilance obligations set forth in the Sublicense Agreement. Should GARDP propose to engage directly in any activities under this Sublicense Agreement for which Shionogi reasonably believes a SDEA would be necessary or prudent, GARDP shall enter into a SDEA agreement in a form reasonably acceptable to Shionogi relative to such activities.
6.2 Quality
GARDP will require its Sublicensees to Manufacture the Licensed Compound and Licensed Product in accordance with standards validated by:
(a) a WHO prequalification; or
(b) any Stringent Regulatory Authority (if the manufacturing site of the Sublicensee has already been approved by a Stringent Regulatory Authority); or
(c) if neither of WHO PQ or an SRA has assessed, by a Third Party GMP audit agreed by both Parties, which audit shall confirm the Sublicensee’s compliance with WHO pre–qualification standards or a Stringent Regulatory Authority’s standards.
Schedule F: Provisions for Sublicense Agreement
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7. Recalls, Market Withdrawals or Corrective Action. In the event that any Regulatory Authority issues or requests a recall or takes a similar action in connection with the Licensed Product in the countries in the Territory covered by the Sublicense, or in the event Sublicensor, Licensor and/or Sublicensee reasonably determine that an adverse event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal in the countries in the Territory covered by the Sublicense, the party notified of such recall or similar action, or the party(ies) that desire(s) such recall or similar action, must within twenty–four (24) hours, advise the other party(ies) by telephone (with written confirmation notice to follow) or by email to the address specified in Section [INSERT REFERENCE TO NOTICE SECTION]. The Parties will consult to decide whether to conduct any recall of Licensed Product in the Territory (except in the case of a Regulatory Authority mandated recall, in which case either Sublicensee or Sublicensor may act without such advance notice but, will notify the other Party and Licensor as soon as possible) and the manner in which any such recall will be conducted, it being understood that any one of Licensor, Sublicensor or Sublicensee may in any case require such a recall to be conducted. Sublicensee shall bear the sole expense of any recall of Licensed Product in the Territory.