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.
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.
Products will bear Seller’s regulatory registration mxxx(s), including Seller’s CE Mxxx.
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.
The Goals shall be based 40% on financial target objectives, 20% on pipeline target objectives (by way of example, for 2014, the Carotid launch, DES project definition, and Peripheral CE Mxxx), 20% on clinical target objectives (by way of example, for 2014, MASTER II enrollment and Carotid CARE study enrollment), and 20% on partnership target objectives (by way of example, for 2014, the execution of two partnership agreements).
GBI shall obtain the CE Mxxx in such foreign countries as ATS may determine.
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).