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. 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. 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. 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. 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. Licensor shall set up, hold, and maintain (at Licensor’s sole cost and expense) the global safety database for Licensed Products. Licensor shall enter into such database all pharmacovigilance and other drug safety data for Licensed Products (including adverse events) in the Licensor Territory and the Licensee Territory as required by Applicable Laws (including any such data collected by licensees, Sublicensees, and other collaboration partners). Licensor shall provide Licensee with ready access to such database (with Licensee bearing any Third Party payment obligations, such as license fees, associated with such access), including to the adverse event information contained therein and Licensor expressly acknowledges that Licensee can and will provide information received by Licensee to Sublicensees engaged in Commercialization activities in the Licensee Territory.
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.
Global Safety Database. Within […***…] after AbbVie proceeds with the In-Licensing, AbbVie shall set up, hold, and maintain (at AbbVie’s sole cost and expense, but subject to the last sentence of this subsection) the global safety database for Licensed Compounds or Licensed Products. Ablynx shall provide AbbVie with all Information necessary or desirable for AbbVie to comply with its pharmacovigilance responsibilities in the Territory, including, as applicable, any adverse drug experiences, from pre-clinical or clinical laboratory, animal toxicology and pharmacology studies, Clinical Studies, and commercial experiences with a Licensed Compound or Licensed Product, in each case in the form reasonably requested by AbbVie.
Global Safety Database. Genmab shall establish, hold (in-house or via an external vendor), and maintain the global safety database for Products with respect to information on adverse events concerning the Products, as and to the extent required by Applicable Law. If (a) any suspected unexpected serious adverse reactions (SUSAR) or any reportable serious adverse events (SAEs) may, in Genmab’s reasonable opinion, have a material impact on the Development of a Product or (b) a public announcement has to be made with respect to a SUSAR or SAE related to a Product, then in each case Genmab shall promptly notify CureVac in writing. If a public announcement has to be made with respect to any SUSAR or SAE related to a Product, Genmab shall, to the extent reasonably possible and provided that this can be done without risk of non-compliance with Applicable Law (including securities laws and stock exchange rules), notify CureVac thereof at least [*****] prior to making such public announcement to give CureVac an opportunity to comment.
