Examples of LipoScience Field of Use in a sentence
LipoScience, solely or with the System Developer or System Manufacturer, will prepare all regulatory filings for the Magnus Analyzer, including all filings required for FDA Approval in the LipoScience Field of Use, with reasonable input and assistance from Varian, and will be responsible for submitting to the FDA or other regulatory authority such applications or other filings for Approval, with all such Approvals required for the LipoScience Field of Use in the name of LipoScience.
The Magnus Analyzer is being designed and developed by the Parties to meet the requirements for use in the LipoScience Field of Use, including without limitation, the need for high throughput, low cost, high reliability, high serviceability, simplicity and ease of use.
LipoScience will be responsible for obtaining Approvals and for subsequent maintenance of Approvals in the LipoScience Field of Use.
Subject to mutually agreed upon limits on the total man-hours of training to be provided at no additional cost to LipoScience, Varian will provide training to LipoScience personnel to enable LipoScience to provide routine periodic customer and field support in the LipoScience Field of Use as described in Sections 6.5 and 6.6 above and to enable LipoScience to provide operational training to its customers on the use of the NMR Subsystem.
LipoScience will have primary responsibility and final decision-making authority for all regulatory matters related to the Magnus Analyzer in the LipoScience Field of Use, including communicating with the FDA.
Varian agrees to provide second tier telephone support for the customers of LipoScience in the LipoScience Field of Use; Varian will supply such support either to the LipoScience support personnel or, at the option of LipoScience, directly to the LipoScience customer.
The LipoScience Project Manager, in its sole discretion, may incorporate such requested features or functions into the Specification for the Magnus Analyzer so long as the LipoScience Project Manager determines that such features or functions will not have a material impact on the Development Plan, the use of the Magnus Analyzer in the LipoScience Field of Use, costs of development or cost of the commercial Magnus Analyzer.
LipoScience will have the right to determine, in its sole discretion, the appropriate marketing and placement strategy for the Magnus Analyzer in the LipoScience Field of Use.
StrategiesThe objective substance of this plan lies in the following strategies.
LipoScience will have the responsibility for providing first tier customer support to its customers in the LipoScience Field of Use for the Magnus Analyzer, including the NMR Subsystem incorporated therein, including providing telephone support.