Common use of Foreign Approvals Clause in Contracts

Foreign Approvals. GBI shall be responsible, on a timely basis, for filing, obtaining and maintaining all necessary "device" or "medical" regulatory approvals from foreign regulatory authorities necessary for the commercial sale of the Products in those foreign countries ("Foreign Approvals") into which the Parties mutually agree Products will be sold. The expense for obtaining such approvals shall be divided evenly between the Parties. If ATS desires to obtain Foreign Approvals for a country and GBI reasonably disagrees that such Foreign Approval is too costly for the anticipated sales in such country, GBI shall proceed to obtain such approval provided ATS agrees to bear the full expense of obtaining such Foreign Approval. All Foreign Approvals shall, to the extent permitted, be in GBI's name. GBI shall obtain the CE M▇▇▇ in such foreign countries as ATS may determine. GBI and ATS shall work together to establish the strategy for obtaining in the most timely and efficient manner the Foreign Approvals to be obtained pursuant to this Section 4.3. GBI's obligations under this Section 4.3 shall include assisting in the preparation and filing of any required submissions relating to future commercial sale of the Products. Except as otherwise required by law or agreed by the Parties, GBI shall be primarily responsible for all dealings with the appropriate competent authority such as notification, medical device vigilance and national labeling issues, and GBI shall bear final legal responsibility for the content of all its own labeling.