Examples of Novartis Licensed Products in a sentence
The purpose of this Development QAG is to ensure a mutual understanding of the roles and responsibilities of FLUIDIGM and NOVARTIS as they relate to the development of Novartis Licensed Products in the Primary Field and Secondary Field per COA.
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.
FLUIDIGM shall ensure or require that all Novartis Licensed Products are stored according to specifications established by the parties during the development of such Novartis Licensed Product.
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.
Subcontractors A third party supplier utilized by FLUIDIGM to perform any of the following activities: • the design and development of Novartis Licensed Products, • the manufacture of Novartis Licensed Products for validation and clinical trial purposes; • the design and/or manufacture of custom components or materials (including software) for Novartis Licensed Products.
Upon request by NOVARTIS or any Regulatory Authority, FLUIDIGM shall provide NOVARTIS with copies of the following documents within an agreed upon period (or as required by any such Regulatory Authority): • Complete device history record of Novartis Licensed Products, • Certificate(s) of analysis of Starting (Raw) Materials, • Certificate(s) of inspection of components used to assemble the device, • Certificate(s) of analysis of primary Packaging Materials and • Test methods used.
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.
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.
Subject to the terms of this Agreement and the Ancillary Agreements, Novartis shall have the sole right to develop and implement the appropriate strategy for obtaining and maintaining regulatory approval for all Novartis Licensed Products in the Primary Field and the Secondary Field in the Territory.
The development plan documents the roles and responsibilities for each party and function, methods for development, strategies for verification and validation, and requirements for commercialization of Novartis Licensed Products.