Examples of Novartis Licensed Products in a sentence
Novartis shall own and retain all right, title and interest in and to all Regulatory Documentation (including regulatory approvals) with respect to Novartis Licensed Products in the Primary Field and Secondary Field in the Territory.
The Novartis Licensed Products produced by FLUIDIGM for use in NORVATIS’ validation and clinical trials will be stored in an appropriate location and environment to reasonably ensure that no damage occurs during storage to such products due to temperature, humidity, dirt, or other harmful agents potentially materially impacting the performance of these products prior to shipment to NOVARTIS or the trial sites.
The press release contains certain non-GAAP financial disclosures for consolidated net income excluding merger-related expenses, diluted earnings per share excluding merger-related expenses, and Commercial and Consumer Banking segment net income excluding merger-related expenses.
For clarity, the manufacture by FLUIDIGM of Novartis Licensed Products in the Primary Field and Secondary Field shall be subject to a separate manufacturing quality agreement.
Manufacturing Lines, Locations All Novartis Licensed Products shall be assembled using location, line and production units which comply with the then-current version of the master manufacturing and packaging procedures described in the Device Master Record (DMR), approved development procedures or the respective/corresponding regulatory dossier.
FLUIDIGM shall make all approved validation protocols, reports, testing protocols, raw data and system operation procedures pertaining to the development of Novartis Licensed Products under the COA available for inspection by NOVARTIS on request.
Since NOVARTIS will rely on decisions made by FLUIDIGM and its critical Subcontractors as defined in FLUIDIGM’s quality system (the list of such critical Subcontractors as set forth in Enclosure C) pertaining to the design, development and/or manufacture of Novartis Licensed Products, this Development QAG also includes a process for the auditing and approval of such FLUIDIGM critical Subcontractors as listed in Enclosure C.
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Reference Standards The reference standards for testing of Novartis Licensed Products, by-products or degradation products will be established by FLUIDIGM and will be provided to NOVARTIS on request.
NOVARTIS and its Affiliates will be the legal manufacturer of the Novartis Licensed Products and will be responsible for the Design History File (“DHF”) for each of the Novartis Licensed Products.