Global Safety Database. Licensee shall establish, hold and maintain (at Licensee’s sole cost and expense) the global safety database for Licensed Products.
Global Safety Database. Licensee shall be responsible for setting up, holding and maintaining (at Licensee’s sole cost and expense) the global safety database for the Licensed Products in the Territory. To the extent required by Applicable Law, upon on Sanofi’s request, Licensee shall grant Sanofi access to such global safety database for the Licensed Products.
Global Safety Database. Mereo shall establish, hold and maintain (at Mereo’s sole cost and expense) the global safety database for Products as required under Applicable Law. Mereo shall provide AstraZeneca with such safety information, including adverse event reports, relating to the Products as AstraZeneca reasonably requires, including to enable AstraZeneca to respond to a request from any applicable Regulatory Authority. To the extent that AstraZeneca requires Mereo to provide AstraZeneca with safety information that constitutes personal data under Applicable Laws relating to privacy pursuant to this Section 6.3, the Parties will agree on reasonable terms for such disclosure in order to ensure compliance with the requirements of Applicable Laws relating to privacy on each Party.
Global Safety Database. Prior to the Option Exercise Date, Xencor shall maintain the global safety database with respect to Products for the Territory. Following the Option Exercise Date, and the transfer to Amgen of such safety database under Section 3.7 above, Amgen or its designee shall maintain the global safety database with respect to the Product for the Territory.
Global Safety Database. Nanobiotix shall maintain the global reference safety database for the Licensed Product. The Pharmacovigilance Agreement will set forth the terms and conditions under which the Parties will share information pertaining to, and each will receive access to, the global reference safety database for the Licensed Product. Lian shall be responsible for safety review (as further described in the Pharmacovigilance Agreement), collection and timely transfer to Nanobiotix of safety data for the Licensed Product in the Field in the Territory. Lian shall transfer such safety data to Nanobiotix in a timely manner according to the Applicable Laws in an electronic format requested by Nanobiotix as further set out in the Pharmacovigilance Agreement, at Lian’s sole cost and expense. Lian shall not be responsible for any costs associated with the global reference safety database.
Global Safety Database. Licensee shall establish, hold and maintain (at Licensee’s sole cost and expense) the global safety database for Licensed Products. MedImmune shall transfer to Licensee the global safety database for the Licensed Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission. Confidential Treatment Requested by Kiniksa Pharmaceuticals, Ltd. Compound and Licensed Products in existence as of the Effective Date and all Information in the possession and Control of MedImmune as necessary for Licensee to comply with its pharmacovigilance responsibilities in the Territory, including, as applicable, any adverse drug experiences (including those events or experiences that are required to be reported to the FDA under 21 C.F.R. sections 312.32 or 314.80 or to foreign Regulatory Authorities under corresponding Applicable Law outside the United States), from pre-clinical or clinical laboratory, animal toxicology and pharmacology studies, clinical studies and commercial experiences with a Licensed Product, in each case, in the form reasonably requested by Licensee.
Global Safety Database. The JCC will establish pharmacovigilance and safety strategy for the Shared Product. Pursuant to such strategy, Vertex will establish the global safety database for such Shared Product. Vertex will maintain a global database of safety information including, but not limited to, adverse events and pregnancy reports for such Shared Product, which will be used for regulatory reporting and responses to safety queries from Regulatory Authorities by both Parties. CRISPR will, and will cause its Affiliates to, transfer all adverse events information in its or their possession or control to the global safety database within a mutually agreed period of time that provides Vertex with sufficient time to enter all of the data and to obtain validation of the database.
Global Safety Database. [***] after the Effective Date, or sooner if agreed between the Parties, Merck shall transfer the global safety database holder for Licensed Product to Urovant and, thereafter, Urovant will maintain the global safety database pursuant to its own policy. Urovant will discuss and execute a safety agreement with Licensee referencing the Licensed Product.
Global Safety Database. In the event that Shore commercializes a Licensed Product outside of the Territory, Santarus and Shore shall enter into a written agreement providing for the establishment of a global safety database by Santarus or its designee to permit the Parties to fulfill local and international regulatory reporting obligations to Regulatory Authorities. The agreement will set forth mutually agreeable guidelines and procedures for the receipt, investigation, recordation, communication and exchange (as between the Parties) and regulatory submission of Adverse Event reports (subject to Section 4.4(a) with respect to the Territory). Santarus shall maintain the global safety database, and, as between the Parties, shall bear all costs with regard to establishing or maintaining such database.
Global Safety Database. [***] will establish and maintain the global database of safety information for each Shared Product (each, a “Global Safety Database”), including adverse events and pregnancy reports for each Shared Product, which will be used for regulatory reporting and responses to safety queries from Regulatory Authorities by both Parties. [***] will, and will cause its Affiliates to, transfer all adverse events information in its or their possession or control to the Global Safety Database within a mutually agreed period of time that provides Vertex with sufficient time for the preparation of required regulatory submissions.
