CGM System definition
Examples of CGM System in a sentence
In the event that, during the Term of this Agreement, MNFR intends to produce, distribute, promote and/or sell any new CGM System, or new products that supersede or are comparable to the CGM System, MNFR shall promptly so notify ALRT in writing and shall provide ALRT with information as is reasonably necessary for ALRT’s evaluation of interest for that new product for the animal health market under this Agreement.
ALRT will provide MNFR with appropriate documentation of defective CGM System including model, serial numbers and the nature of the defect.
In addition, ADC shall be solely responsible for obtaining and maintaining integrated continuous glucose monitoring approval from the FDA for the CGM System for commercialization in the United States.
When requested by ADC, Beta shall provide reasonable support, including (i) participation in joint meetings with Authorities to assist in obtaining and maintaining regulatory approval of the CGM System that can be used with the Libre-Beta System, and (ii) for testing and verification of the incorporation of the data generated by the CGM System into the Libre-Beta System.
Each Party shall keep the other Party reasonably informed of planned Beta System or CGM System updates or any planned cloud-to-cloud data API interface updates, as applicable (whether software updates or hardware modifications), if such updates will or could reasonably be expected to impact the integration, features, functions or capabilities of the Libre-Beta System [***].
During the Term, MTIA shall have the right to enter into good faith negotiations with Echo for an agreement with respect to any improvements or modifications to current Echo’s Symphony™ CGM System or any of Echo’s new products.
The time period of such changes will be cooperatively established so as to limit the production costs of the CGM System.
If any Specification change requested by ALRT affects MNFR’s costs of manufacturing, testing, labeling, packaging or storing the CGM System adversely, the Parties will negotiate, in good faith, an adjustment to the pricing set forth in Exhibit C hereof.
If the changes induced by such modification materially affect the nature or quality of the CGM System, the Parties will negotiate, in good faith, an adjustment to the pricing set forth in Exhibit C hereof for a modification required pursuant to this clause (6)(c).
Beta shall provide a pre-production environment and any necessary support to facilitate ADC’s testing and, if necessary, modification of any CGM System required for the conduct of the Development Plan.