EnSite System definition
Examples of EnSite System in a sentence
The term “Fully Integrated System” means a computerized interventional electrophysiological system comprising one Fully Integrated EnSite System and one Fully Integrated Sensei System.
If either party is required to submit any information concerning the H▇▇▇▇▇ Products or the Fully Integrated EnSite System as part of a regulatory inspection or audit in connection with the manufacture and sale of the H▇▇▇▇▇ Products or the Fully Integrated EnSite System, either party will provide to the other party such documentation, data and other information as may be required for submission to the regulatory agency.
Each of the parties agrees to notify the other within three (3) Business Days of receipt of any significant complaint or information relating to the safety or effectiveness of any H▇▇▇▇▇ Products or Fully Integrated EnSite System or otherwise relating to an event that could trigger a need to file a Medical Device Report (“MDR”).
Each party shall provide reasonable assistance to the other, at no charge, if necessary to respond to regulatory audits, inspections, inquiries or requests concerning the H▇▇▇▇▇ Products or the Fully Integrated EnSite System.
Unless otherwise agreed in writing by the parties, H▇▇▇▇▇ shall promptly return such EnSite System to St. Jude, at H▇▇▇▇▇’▇ expense, in good working order, reasonable wear and tear excepted, upon the expiration of the Term or any termination of this Agreement.
The parties will notify each other within two Business Days of learning of any material regulatory development with respect to H▇▇▇▇▇ Products or the Fully Integrated EnSite System.
Each party shall, if required, also provide to the regulatory agency or to the other party, as applicable, information concerning its quality control procedures and marketing of the H▇▇▇▇▇ Products or the Fully Integrated EnSite System and any other information reasonably requested by the regulatory agency.
In the event that the party in control of a product (i.e., H▇▇▇▇▇ controls the H▇▇▇▇▇ Products and St. Jude controls the Fully Integrated EnSite System) determines that any Remedial Action with respect to a product must be commenced or Remedial Action is required by any governmental authority having jurisdiction over the matter, the party in control of such product will control and coordinate all efforts necessary to conduct such Remedial Action.
During the Term, St. Jude shall provide to H▇▇▇▇▇, one EnSite System, on loan and free of charge, and related disposables, at a transfer price to be determined as part of the Sales and Marketing Plan, for sales demonstration and training purposes under this Agreement.
With respect to each H▇▇▇▇▇ Product or each Fully Integrated EnSite System covered by such notification, the party in control of the subject product shall provide to the other party a minimum of the following information within five days following receipt of the notification: (i) Device History Record evaluation, (ii) Batch/Lot size and (iii) Assurance Record (visual, dimensional, functional inspections or process controls).