Forward Traceability Sample Clauses

Forward Traceability. CMS shall develop a forward traceability program and protocol so that End Customers can be notified of any safety issues, Product recall or market withdrawal of the Product. At a minimum, such forward traceability program and protocol shall capture (a) the contact information of the End Customer; (b) the contact information for the relevant Designated Party, distributor or reseller; (c) date of Product production; (d) contact information for any intermediary consignees of the relevant Product; (e) contact information, if available, for the End Customer’s health care provider; (f) whether the Product is the result of the Importation Paradigm or the Localization Paradigm; (g) if the Product is the result of the Localization Paradigm, the site(s) where the Bulk Product was Manufactured to the Finished Product; and (h) the Unique Device Identifier number, catalog number and batch/lot number for the relevant Product. At least sixty (60) days prior to the date of the First Commercial Sale of the Product in the Territory, CMS shall provide such written program and protocol to Gelesis for its review and comment. Gelesis will provide, in writing, comments and requested modifications as to such program and protocol within twenty (20) days of receipt from CMS. CMS shall incorporate such modifications or changes to its forward traceability program and protocol as requested by Gelesis.