Global Database Clause Samples
Global Database. Cubist shall be responsible for compiling a validated global database that captures all adverse events reported to Cubist from any source and maintaining said database as defined in any associated Quality Agreement. Cubist shall also provide Chiron with as close to immediate access as possible to such global database so as to support the applications for Regulatory Approval and the maintenance of marketing authorizations in the Territory, PROVIDED that it is technically feasible to do so and that Chiron makes payment of any incremental license fees that may be required in order add Chiron as an authorized user.
Global Database. To the extent required under applicable Law, after the effective date of transfer of Marketing Approval of a Product as per Section 4.2, Theratechnologies shall be responsible for the implementation of a database to allow tracking, trending and signal detection of Adverse Events attributable to the use or application of such Product in the Territories, provided, however, that in the event TaiMed implements a global database, Theratechnologies’ responsibility shall be limited to reporting Adverse Events that occurred in the Territories on such global database. Upon issuance of any authorization to market and sell such Product outside of the Territories, TaiMed shall be responsible for the implementation of a global database to allow tracking, trending and signal detection of Adverse Events attributable to the use or application of such Product worldwide.
Global Database. Following the initiation of a Phase I Study for any Product by Infinity, its Affiliates or Sublicensees, Infinity shall, itself or through its Affiliate or a Third Party, establish and maintain a worldwide safety database for Products. Such database shall comply in all material respects with all Laws reasonably applicable to pharmacovigilance anywhere the Products are being or have been Developed or Commercialized. The costs associated with establishing and maintaining such database shall be considered a Research and Development Expense. Infinity shall consult with MICL with respect to the selection of a Third Party to establish or maintain such database.
Global Database. Until an NDA is filed in the Territory covering a Licensed Product, IDEA will be responsible for establishing and maintaining a worldwide safety database for Licensed Products which is suitable in form and substance for ALPHARMA to submit to the FDA in support of ALPHARMA's NDA for the Licensed Product and which otherwise complies with all laws, rules and regulations applicable thereto. After such filing of an NDA covering a Licensed Product in the Territory, IDEA shall continue to be responsible for maintaining such a worldwide safety database, but ALPHARMA shall have primary responsibility for the safety database for the Territory. Each Party shall provide information for the worldwide safety database on a prompt basis and as required by applicable laws, rules and regulations, and appropriate personnel of both Parties shall have full and immediate access to such database (including electronic access to the extent practicable), and shall be authorized to submit data from the database to applicable Regulatory Authorities as required or permitted by all applicable laws, rules and regulations.