Common use of HD Licensed Products After Co-Co U Clause in Contracts

HD Licensed Products After Co-Co U. S. Option Exercise. If, and only if, Genzyme has exercised the Co-Co Option, this Section 7.1.9.2 shall apply to HD Licensed Products in the United States instead of Section 7.1.9. 1. In the event that the FDA issues or requests a recall or takes a similar action in connection with an HD Licensed Product in the United States, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal of an HD Licensed Product in the United States, the Party notified of such recall or similar action, or the Party that desires such recall or similar action, shall, within [***] of such request, order or determination, notify the other Party’s Alliance Manager and PSC representatives for such HD Licensed Product by telephone or e-mail. The Parties shall mutually agree whether to conduct a recall of an HD Licensed Product in the United States and the manner in which any such recall shall be conducted (except in the case of a government mandated recall, when CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. the Party subject to such mandate may act without such advance notice but shall notify the other Party as soon as possible); provided, however, if the Parties are unable to mutually agree as to whether to conduct a recall of an HD Licensed Product in the United States, then [***]. Except as may be otherwise agreed by the Parties, each Party shall share equally the expense of any such recall in the United States. Each Party will make available all of its pertinent records that may be reasonably requested by the other Party in order to effect a recall of an HD Licensed Product in the United States. The Parties’ rights and obligations under this Section 7.1.9.2 shall be subject to the terms of any supply agreement(s) entered into between the Parties and, in the event of any conflict between the provisions of any such supply agreement and this Section 7.1.9.2, the provisions of such supply agreement shall govern.