Common use of Product Notices Clause in Contracts

Product Notices. Company shall monitor adverse event and other failure reports or complaints and promptly advise Saint Luke’s of information indicating a significant trend of adverse events, consumer or practitioner complaints, or failures or injuries related to the use of the Products. Company agrees to send all Product notices (inclusive of notices of any changes affecting the Products and notices of new products) to Saint Luke’s. Company will promptly provide Saint Luke’s (via letter, e-mail or other similar form of communication) with any and all information regarding any routine backorders of Products, Product changes, Product packaging changes, safety announcements, and clinical information regarding Products. Company shall immediately provide Saint Luke’s with a copy of all communications from Company and/or the FDA advising of a recall, request for a recall, market withdrawal, safety alert, or a non-routine issue of Product availability (e.g. significant backorders of Products). Company shall provide Saint Luke’s with written notice of any Class I recall, whether voluntary or initiated by the FDA, affecting any of the Products within twenty-four (24) hours of Company’s receipt of any such request for a recall, or shorter period of time provided in the recall strategy. Company shall reimburse Saint Luke’s for any costs actually incurred by Saint Luke’s in complying with any recall instructions and processes provided by Company. In addition, Company shall, at no additional cost to Saint Luke’s, replace any such Products which are the subject of a recall with Company products which have been approved by Saint Luke’s as being clinically equivalent to the recalled products. 12.3.1 In the event Products are required to be modified to comply with any regulatory or safety standards imposed or implemented for such Product, Company shall, for Products previously purchased by Saint Luke’s hereunder, at no cost to Saint Luke’s provide hardware modifications necessary for the Products to meet all such regulatory requirements or shall exchange the Products for new Products that comply with the new requirements.