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.
FDA Clearance. 4.1 BioStar shall use commercially reasonable efforts to obtain FDA Clearance of a Diagnostic. BioStar must prepare an application for FDA Clearance of a Diagnostic in accordance with the Development Work Plan and shall provide Biota with a draft application and all relevant materials for submission as part of the application to the FDA in relation to the Diagnostic as soon as possible. BioStar must obtain Biota's prior written consent before lodging any original application for FDA Clearance such consent not to be unreasonably withheld.
4.2 Biota undertakes to review promptly any application for FDA Clearance submitted to it by BioStar, whether provided in whole or in part. In the event Biota fails to respond to BioStar within 30 days' after receiving any such materials Biota shall be deemed to have approved those materials.
4.3 Following submission of an application for FDA Clearance of the Diagnostic, BioStar must make all reasonable efforts to discuss the provision of any additional information to the FDA and must promptly make available to Biota copies and details of all information used or provided to FDA for the purposes of obtaining FDA Clearance of the Diagnostic, including records of conversations with the FDA and correspondence from or other information provided by or to the FDA, and must keep Biota fully informed of progress of the application for FDA Clearance of the Diagnostic. BioStar must use all reasonable efforts to maintain the confidentiality of any information containing or relating to Foreground IP or Biota IP and must request confidential treatment of the same by the FDA.
4.4 Biota agrees to pay BioStar the sum of [ * ] within 30 days after the grant of FDA Clearance of the Diagnostic.
4.5 BioStar shall provide Biota with such assistance (including executing documentation and assignments) as may be reasonably required by Biota to obtain regulatory approval to the use of the Diagnostic in the diagnosis of influenza in countries other than the US.
4.6 If FDA Clearance of a Diagnostic is obtained, BioStar shall immediately notify Biota and provide Biota with copies of the FDA Clearance of the relevant Diagnostic and any associated materials.
4.7 In addition to any other specific obligations under this Agreement, each party agrees with the other that it will comply with all applicable legislation, regulations and governmental requirements insofar as the same apply to it in the manufacture, use or sale of the Diagnostic.
FDA Clearance. PHMD shall be entitled to submit application with the FDA for a general 510(k) clearance for the Licensed Product in its own name. It shall do so no later than seventy-five (75) days after Completion. XXXXX shall cooperate with PHMD and provide all necessary documentation and information on the Licensed Product to such end.
FDA Clearance. 5.01. INTRACEL shall, at its own expense, obtain all necessary clearances from governmental agencies to market each Product. Said request for market clearance shall be filed with the necessary governmental agencies by INTRACEL as soon as reasonably practical after a commercial embodiment of such Product is developed by or for INTRACEL. TJU agrees to cooperate with INTRACEL and to provide reasonable assistance where appropriate in obtaining any such clearance. INTRACEL shall indemnify, defend, and hold harmless TJU, its trustees, officers, staff and agents from any and all liability, judgments or expenses arising from failure to obtain any such clearance or violation of any governmental regulation related to the Product(s).
FDA Clearance. Subject to the terms and conditions contained in this Agreement, MATRITECH agrees to exert commercially reasonable efforts to seek, as soon as practicable, diagnosis clearance from the FDA for the Product in the Territory. Diagnosis clearance shall mean approval by the FDA to use the Product for the diagnosis of bladder cancer on patients other than those with reoccurring bladder cancer. MATRITECH shall promptly notify CYTOGEN in writing in the event MATRITECH does not obtain diagnosis clearance from the FDA.
FDA Clearance. (a) If the Platform or any products developed under this Agreement is subject to any FDA regulation, HeartBeam will fulfill all corresponding regulatory requirements and LIVMOR will, at HeartBeam’s expense (including reasonable TME), provide all reasonable support and assistance that HeartBeam may require, including that LIVMOR will promptly provide HeartBeam with any such registration, clearance, or approval documentation. If LIVMOR decides to seek any licenses, permits, or approvals, or to take any action that may impose any obligations or limitations on the Platform or other products developed for HeartBeam under this Agreement, then LIVMOR will immediately notify HeartBeam, and will use their commercially reasonable efforts to minimize the effect of such regulation, obligation, or limitation, to the extent reasonably practicable.
FDA Clearance. Cytogen represents that, upon delivery to -------------- Distributor, Products will have been approved by the FDA to be marketed in the United States, and that all international, federal and state approvals and permits for the manufacture, importation, design, testing, inspection, labeling, and instructions for use, sale and distribution of Products in the United States have been obtained. Cytogen agrees that it shall be solely responsible for, and comply with, all applicable international, federal and state laws governing the regulation of the manufacture, importation, design, testing, inspection, labeling, sale, and instructions for use of the Product in the United States and its Territories.
FDA Clearance. The PROW FUSION-V FDA Clearance shall remain in full force and effect and shall not have been rescinded.
FDA Clearance a) MANUFACTURER represents and warrants that the Food and Drug Administration (“FDA”) has approved the Products for distribution within the Territory. Upon DISTRIBUTOR’s request, MANUFACTURER shall provide evidence of such approval to DISTRIBUTOR as is reasonably required by DISTRIBUTOR to comply with applicable laws and regulations.
b) MANUFACTURER shall not deliver to DISTRIBUTOR any Products that have not cleared or approved by the FDA for distribution within the Territory.
FDA Clearance. Upon Given sending to EES the complete copy of the FDA Clearance of the ECE for adults, EES shall pay to Given:
(a) ten (10) million US $, if the FDA Clearance has been obtained by or before December 31, 2004.
(b) nine (9) million US $, if the FDA Clearance has been obtained by or before March 31, 2005.
(c) eight (8) million US $, if the FDA Clearance has been obtained by or before June 30, 2005. _________________________ < * * * > Omitted pursuant to a confidential treatment request. The confidential information has been separately filed with the SEC.
