Freezone® Product definition
Examples of Freezone® Product in a sentence
Distributor shall also ensure that all packaging and labeling provided for the Promo Footcare Product contains language (including applicable warnings and cautionary language) required under all applicable treaties, laws, rules and regulations for the inclusion of the Freezone® Product as a component of the Promo Footcare Product, including under all applicable FDA or other regulatory approvals, clearances or registrations.
In addition, Distributor shall have primary responsibility for investigating and responding to all complaints or adverse events or reactions related to the Freezone® Product or the use thereof.
Distributor shall be solely responsible for, and shall reimburse OSUR for, any costs associated with any recall, replacement or other similar action involving the Promo Footcare Product to the extent arising from the Freezone® Product or the use thereof in any manner or any labeling or warnings related thereto.
Distributor represents, warrants and agrees that the Freezone® Product shall be manufactured in accordance with and shall comply with the specifications set forth in the Freezone® Specifications.
Distributor shall be solely responsible for obtaining and maintaining, at its sole cost, all regulatory approvals, clearances or registrations, including all applicable FDA approvals, required for the manufacture, sale or distribution of the Freezone® Product in the OTC Market.
Distributor shall ensure that the Freezone® Product is manufactured, packaged and labeled in compliance with all applicable treaties, laws, rules and regulations, including all applicable FDA or other regulatory approvals, clearances or registrations required for the manufacture, sale or distribution of the Freezone® Product.