MUSE System definition

MUSE System means Vivus' system for delivery of the Product to treat erectile dysfunction, as modified from time to time during the term of this Agreement.

Examples of MUSE System in a sentence

  • Vivus agrees to keep Spolana reasonably informed as to the status of the development and applications for regulatory approvals of the MUSE System incorporating the Product supplied hereunder.

  • All Product supplied by Spolana shall meet (i) the current USP and European Pharmacopoeia requirements for the Product, (ii) the current Specifications, (iii) additional requirements that the parties may agree to from time to time to reflect to the manufacturing requirements of Vivus' MUSE System and (iv) the requirements of any health regulatory agency to which Vivus has submitted, or notifies Spolana it will submit or sponsor the submission of, an application for regulatory approval.

  • From time to time during the term of this Agreement, Spolana shall provide letters of authorization, instruments and/or documents, and take such other actions, as Vivus may reasonably request for purposes of obtaining regulatory approvals necessary for Vivus and its marketing partners to import, export and sell Product as incorporated into the MUSE System and/or other products worldwide.

  • Vivus and its marketing partners shall notify Spolana in a timely fashion about their requirements for the submission and maintenance of DMFs related to the manufacture and control of the Product adequate to comply with applicable regulatory agencies' (including without limitation the FDA's) standards with respect to the Product in the United States, Europe and Canada and other countries as is or becomes necessary for Vivus and its marketing partners to import, export and sell the MUSE System worldwide.

  • The MUSE System is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach in order to create anterior partial fundoplication for treatment of symptomatic chronic Gastro Esophageal Reflux Disease in patients who require and respond to pharmacological therapy.

  • Condition or disease Intervention/treatment Gastroesophageal Reflux Disease (GERD) Device: Medigus Ultrasonic Surgical Endostapler (MUSE) Procedure Detailed Description: The registry evaluates the MUSE System which creates a transoral anterior fundoplication for the treatment of GERD.

  • The modified MUSE System has the same intended use, indications, principles of operation and fundamental technology as the cleared, predicate version of the device.

Related to MUSE System

  • E-System means any electronic system approved by Agent, including Intralinks® and ClearPar® and any other Internet or extranet-based site, whether such electronic system is owned, operated or hosted by Agent, any of its Related Persons or any other Person, providing for access to data protected by passcodes or other security system.

  • Levee system means a flood protection system which consists of a levee, or levees, and associated structures, such as closure and drainage devices, which are constructed and operated in accordance with sound engineering practices.

  • Sewage system means the entire sewage treatment and subsurface disposal system;

  • Cable System means a facility, consisting of a set of closed transmission paths and associated Signal generation, reception, and control equipment, that is designed to provide Cable Service, which includes Video Programming and which is provided to multiple Subscribers within a community, but “Cable System” does not include:

  • Supported Wage System means the Commonwealth Government System to promote employment for people who cannot work at full award wages because of a disability.

  • The System means an electronic control system or complex electronic control system that provides or forms part of the control transmission of a function to which this Regulation applies. This also includes any other system covered in the scope of this Regulation, as well as transmission links to or from other systems that are outside the scope of this Regulation, that acts on a function to which this Regulation applies."

  • Drainage system means one or more artificial ditches, tile drains or similar devices which collect surface runoff or groundwater and convey it to a point of discharge.

  • SDX System means the system used by NERC to exchange system data.

  • XXXXX System means the XXXXX filing system of the Commission and the rules and regulations pertaining thereto promulgated by the Commission in Regulation S-T under the Securities Act and the Exchange Act, in each case as the same may be amended or succeeded from time to time (and without regard to format).

  • Interstate system means that portion of the National System of Interstate and Defense Highways located within this State, as officially designated, or as may hereafter be so designated, by the Department of Transportation, and approved by the Secretary of Commerce or other appropriate federal official, pursuant to the provisions of Title 23 of the United States Code.

  • State Systems means the information technology infrastructure, including the computers, software, databases, electronic systems (including database management systems) and networks, of the State or any of its designees.

  • Pipeline System means each system of Pipeline Assets, Real Property and Easements relating thereto making up an integrated gathering system and gathering system, or other pipeline system.

  • Installation Services means all those services ancillary to the supply of the Plant and Equipment for the Facilities, to be provided by the Contractor under the Contract; e.g., transportation and provision of marine or other similar insurance, inspection, expediting, site preparation works (including the provision and use of Contractor’s Equipment and the supply of all construction materials required), installation, testing, pre-commissioning, commissioning, operations, maintenance, the provision of operations and maintenance manuals, training, etc.

  • Sewerage system means pipelines or conduits, pumping stations, and force mains, and all other

  • Energy storage system means a system which stores energy and releases it in the same form as was input.

  • 911 system means the set of network, database and customer premise equipment (CPE) components required to provide 911 service.

  • Managed health care system means: (a) Any health care

  • Utility system means a water system, solid waste

  • Capture system means the equipment (including hoods, ducts, fans, etc.) used to contain, capture, or transport a pollutant to a control device.

  • PV System means a residentially hosted roof-top solar electric generating system, including photovoltaic panels, racks, wiring and other electrical devices, conduits, weatherproof housings, hardware, one or more inverters, remote monitoring systems, connectors, meters, disconnects and over current devices.

  • Automated driving system means the same as that term is defined in Section 41-26-102.1.

  • Clearance System means the principal domestic clearance system customarily used for settling trades with respect to the Underlying as determined by the Calculation Agent acting in accordance with relevant market practice and in good faith.

  • TARGET2 System means the Trans-European Automated Real-Time Gross Settlement Express Transfer (TARGET2) system or any successor thereto.

  • SCADA System means the Supervisory Control and Data Acquisition System which is composed of all telemetering and remote terminal units (“RTU”) at the Facility and associated with the Grid System or BPDB’s Control Center;

  • Network Area means the 50 mile radius around the local school campus the Named Insured is attending.

  • Customer System means the Customer's computing environment (consisting of hardware, software and/or telecommunications networks or equipment) used by the Customer or the Supplier in connection with this Contract which is owned by or licensed to the Customer by a third party and which interfaces with the Supplier System or which is necessary for the Customer to receive the Services;