Product Inserts and Labeling. DIAMETRICS shall be responsible for the text and regulatory compliance of all package labels and Product inserts used in connection with the Products (except Portal Products). PHILIPS shall be responsible for the text and regulatory compliance of all package labels and product inserts used in connection with Portal Products. All Portal Product labels and labeling shall be as set forth in the current specifications for the Portal Product. For purposes of this Agreement, the terms "label" and "labeling" shall have the meanings set forth in Sections 201(k) and 201(m) respectively of the U.S. Federal Food, Drug and Cosmetics Act.
Appears in 4 contracts
Samples: Manufacturing and Distribution Agreement (Diametrics Medical Inc), Manufacturing and Distribution Agreement (Diametrics Medical Inc), Manufacturing and Distribution Agreement (Koninklijke Philips Electronics Nv)
