FDA Clearance. Wescor shall use its best efforts with all reasonable speed and efficiency to conduct and complete, or cause MicroCor to conduct and complete, such actions as are reasonably necessary to gather data and prepare a 510(k) Premarket Notification submission to the FDA covering the Product(s) and to obtain the necessary clearances from the FDA to market such Product(s) in the United States market ("FDA Clearance"). In the event MicroCor's Board of Directors determines that Wescor has acted in good faith in the performance of its obligations to obtain FDA Clearance but such FDA Clearance has not been obtained, and the Board of Directors further determines that it is reasonable to expect that FDA Clearance will be obtained in the future, the Board of Directors may extend for six (6) months the period described in clause (ii) of Section 5.1.3, which extension would also automatically extend the period described in clause (iii). Upon subsequent identical determinations by MicroCor's Board of Directors, additional six-month extensions may be granted in the Board's discretion.
Appears in 3 contracts
Sources: Joint Development Agreement (Inmedica Development Corp), Joint Development Agreement (Inmedica Development Corp), Joint Development Agreement (Inmedica Development Corp)