FDA Agreement Sample Clauses

FDA Agreement. Where a FDA is agreeable in principle, the Manager will negotiate a FDA agreement that provides for the following: • A transition period that is at least 3 months but no more than 6 months before the date of departure. • Specifies the reduction in hours where the proposed transition period involves a reduction in hours worked. • Provides for the employee to resign with effect from the agreed date of departure. • Provides for periodic reviews (at not less than monthly intervals) to ensure that the FDA continues to satisfy the criteria set out in above; • Provides for cancellation of the FDA without compensation in the event that any of the criteria set out in paragraph 1 and 2 are no longer satisfied. • Provides measure, if appropriate, for the transfer of responsibilities to a new incumbent. • Provides for the completion of any outstanding reporting, administration or other work- related matters. • Provides for agreement on the amount of the flexible departure payment determined in accordance with this clause. “Satisfactory work record” Satisfactory work record will be determined by reference to the employee’s overall previous conduct and performance. The Ministry’s assessment of the employee’s work record must be reasonable and undertaken in good faith. In particular: • The Ministry will advise the employee of any matters that may constitute an unsatisfactory work record and consider any reasons advanced by the employee why the employee’s work record should not be considered unsatisfactory in relation to those matters. • In reaching a conclusion on the employee’s work record, the Ministry must take a balanced approach; any proven non-performance or misconduct will be weighed against any positive factors or mitigating circumstances. • If the employee’s work record is regarded as unsatisfactory by reason of proven misconduct or non-performance then the Manager may decided to withhold the flexible departure payment either in whole or in part, having regard to the extent to which the work record has been affected by the misconduct or non-performance.

FDA Agreement. To the extent that a Change Request accepted or proposed by Collingwood will require any filing with any Regulatory Authority or the granting of any Regulatory Approval for the Product, each Party shall reasonably cooperate with each other and take all reasonable actions and provide all information as may be reasonably requested by Collingwood or Ovamed in connection with preparing such filings and obtaining such Regulatory Approval. Costs incurred by Ovamed in connection with the above will be subject to the terms of Sections 6.1.1 and 6.1.2 above. Without limiting any other provision of this Article 6, Ovamed will not change any aspect of the Product or the process by which the Product is manufactured that requires the FDA approval if the FDA does not provide written confirmation, prior to making the change, that the change will not terminate or otherwise impair any Regulatory Approval for the Product. Collingwood will support and assist Ovamed in any communications with the FDA that may be required as described above in order to achieve such FDA confirmation.