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.
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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.
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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.
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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.
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Related to Global Database

  • Global Safeguard Measures Each Party retains its rights and obligations under Article XIX of the GATT 1994 and the WTO Agreement on Safeguards. In taking measures under these WTO provisions, a Party shall, consistent with WTO law and jurisprudence and in accordance with its domestic legislation, exclude imports of an originating product from one or several Parties if such imports do not in and of themselves cause or threaten to cause serious injury.

  • Database The LERG is available through Telcordia. ICONN is available through the Qwest web site.

  • Global Securities (a) If the Company shall establish pursuant to Section 2.01 that the Securities of a particular series are to be issued as a Global Security, then the Company shall execute and the Trustee shall, in accordance with Section 2.04, authenticate and deliver, a Global Security that (i) shall represent, and shall be denominated in an amount equal to the aggregate principal amount of, all of the Outstanding Securities of such series, (ii) shall be registered in the name of the Depositary or its nominee, (iii) shall be delivered by the Trustee to the Depositary or pursuant to the Depositary’s instruction (or if the Depositary names the Trustee as its custodian, retained by the Trustee), and (iv) shall bear a legend substantially to the following effect: “Except as otherwise provided in Section 2.11 of the Indenture, this Security may be transferred, in whole but not in part, only to another nominee of the Depositary or to a successor Depositary or to a nominee of such successor Depositary.” (b) Notwithstanding the provisions of Section 2.05, the Global Security of a series may be transferred, in whole but not in part and in the manner provided in Section 2.05, only to another nominee of the Depositary for such series, or to a successor Depositary for such series selected or approved by the Company or to a nominee of such successor Depositary. (c) If at any time the Depositary for a series of the Securities notifies the Company that it is unwilling or unable to continue as Depositary for such series or if at any time the Depositary for such series shall no longer be registered or in good standing under the Exchange Act, or other applicable statute or regulation, and a successor Depositary for such series is not appointed by the Company within 90 days after the Company receives such notice or becomes aware of such condition, as the case may be, or if an Event of Default has occurred and is continuing and the Company has received a request from the Depositary or from the Trustee, this Section 2.11 shall no longer be applicable to the Securities of such series and the Company will execute, and subject to Section 2.04, the Trustee will authenticate and deliver the Securities of such series in definitive registered form without coupons, in authorized denominations, and in an aggregate principal amount equal to the principal amount of the Global Security of such series in exchange for such Global Security. In addition, the Company may at any time determine that the Securities of any series shall no longer be represented by a Global Security and that the provisions of this Section 2.11 shall no longer apply to the Securities of such series. In such event the Company will execute and, subject to Section 2.04, the Trustee, upon receipt of an Officer’s Certificate evidencing such determination by the Company, will authenticate and deliver the Securities of such series in definitive registered form without coupons, in authorized denominations, and in an aggregate principal amount equal to the principal amount of the Global Security of such series in exchange for such Global Security. Upon the exchange of the Global Security for such Securities in definitive registered form without coupons, in authorized denominations, the Global Security shall be canceled by the Trustee. Such Securities in definitive registered form issued in exchange for the Global Security pursuant to this Section 2.11(c) shall be registered in such names and in such authorized denominations as the Depositary, pursuant to instructions from its direct or indirect participants or otherwise, shall instruct the Trustee. The Trustee shall deliver such Securities to the Depositary for delivery to the Persons in whose names such Securities are so registered.

  • Regulation S Global Security to Restricted Global Security If a holder of a beneficial interest in a Regulation S Global Security deposited with or on behalf of DTC wishes at any time to transfer its interest in such Regulation S Global Security to a Person who wishes to take delivery thereof in the form of an interest in a Restricted Global Security, such holder may, subject to the rules and procedures DTC, exchange or cause the exchange of such interest for an equivalent beneficial interest in a Restricted Global Security. Upon receipt by the Trustee, as Certificate Registrar, of (I) instructions from DTC directing the Trustee, as Certificate Registrar, to cause to be credited a beneficial interest in a Restricted Global Security in an amount equal to the beneficial interest in such Regulation S Global Security to be exchanged but not less than the minimum denomination applicable to such holder’s Certificates held through a Restricted Global Security, to be exchanged, such instructions to contain information regarding the participant account with DTC to be credited with such increase, and (II) a certificate in the form of Exhibit N-2 hereto given by the holder of such beneficial interest and stating, among other things, that the Person transferring such interest in such Regulation S Global Security reasonably believes that the Person acquiring such interest in a Restricted Global Security is a QIB, is obtaining such beneficial interest in a transaction meeting the requirements of Rule 144A and in accordance with any applicable securities laws of any State of the United States or any other jurisdiction, then the Trustee, as Certificate Registrar, will reduce the principal amount of the Regulation S Global Security and increase the principal amount of the Restricted Global Security by the aggregate principal amount of the beneficial interest in the Regulation S Global Security to be transferred and the Trustee, as Certificate Registrar, shall instruct DTC, concurrently with such reduction, to credit or cause to be credited to the account of the Person specified in such instructions a beneficial interest in the Restricted Global Security equal to the reduction in the principal amount of the Regulation S Global Security.

  • Database File The Servicer will provide the Successor Servicer with a data file (in a format reasonably acceptable to the Indenture Trustee and the Servicer) containing the database file for each Contract (i) as of the Cutoff Date, (ii) thereafter, as of the last day of the preceding Due Period on each Determination Date prior to a Servicing Transfer, and (iii) on and as of the Business Day before the actual commencement of servicing functions by the Successor Servicer following the occurrence of a Servicing Transfer.