Examples of CE Mxxx in a sentence
All data necessary to obtain CE Mxxx and FDA approvals will be the responsibility of Supplier and Supplier shall make such data available to Distributor for use in obtaining regulatory approvals in the Territory at no charge.
Distributor shall be responsible for obtaining all import, regulatory and reimbursement registrations and approvals that are necessary or advisable for sales of the Products in the Territory and for the performance of its duties hereunder (collectively, “Regulatory Approvals”); provided, however, that Supplier shall be responsible for obtaining CE Mxxx and FDA approvals with respect to the Products.
This Agreement will take effect as of the date first above written and, unless terminated earlier pursuant to Section 7.2, will continue in force until three (3) years after the date that the first CE Mxxx approval has been obtained for any of the Products (the “CE Approval”), at which time this Agreement will automatically expire and terminate unless the parties mutually agree otherwise in writing.
Cxxx will be solely responsible for the preparation and filing of all documents required in connection with seeking and obtaining regulatory approval of Products in the Field in each country in the Territory, at its sole expense and discretion, including without limitation the CE Mxxx, IDE applications and PMA (or equivalent) approvals, and will solely own all rights in such documents and approvals.
Notwithstanding the foregoing, Z-KAT agrees and covenants to transfer, assign or otherwise deliver to Company all documentation (including, without limitation, any regulatory submission documents, e.g. 510k submissions, CE Mxxx technical files, etc.
GBI shall obtain the CE Mxxx in such foreign countries as ATS may determine.
Without limiting the foregoing, Cxxx will use commercially reasonable efforts to apply for a CE Mxxx and FDA Approval within a reasonable period of time after the development of a Feasible Prototype.
The Parties agree that all regulatory costs for receiving CE Mxxx for the Licensed Product shall be borne fifty percent (50%) by Licensee and fifty percent (50%) by Licensor; provided, however, that Licensor’s obligations under this Section 3.1 shall not exceed eighty five Thousand Dollars ($85,000).
Distributor shall be responsible for obtaining all import, regulatory and reimbursement registrations and approvals that are necessary or advisable for sales of the Products in the Territory (including but not limited to “Shonins” in Japan) and for the performance of its duties hereunder (collectively, “Regulatory Approvals”); provided, however, that Supplier shall be responsible for obtaining CE Mxxx and FDA approvals with respect to the Products.
Products will bear Seller’s regulatory registration mxxx(s), including Seller’s CE Mxxx.