Debarment Proceedings. During the Term, neither of the parties shall knowingly use any employee, representative, agent, assistant or associate who has been debarred by the FDA pursuant to 21 U.S.C. Section 335 (a) or (b) of the United States Federal Food Drug and Cosmetic Act (21 U.S.C. Section 301 et seq.), as amended from time to time, in connection with any of the activities to be carried out under this Agreement. In addition, as of the Effective Date, neither party is subject to any proceeding by any regulatory authority having jurisdiction over the registration, manufacture or marketing of pharmaceutical products which could reasonably be expected to prevent or delay such party’s completion of its responsibilities under the Development Plan.
Appears in 2 contracts
Sources: Collaboration and Commercialization Agreement (Replidyne Inc), Collaboration and Commercialization Agreement (Replidyne Inc)