Common use of Regulatory Timelines Clause in Contracts

Regulatory Timelines. (a) Within thirty (30) days of the Effective Date, Orphan Medical shall (i) transfer the Orphan Medical Drug Designation in the Territory from IDIS World Medicines to Celltech, and (ii) provide Celltech with the NDA and the Know How and the related Proprietary Information to enable Celltech to prepare and timely file the applications to commercially promote and distribute the Product for the cataplexy Licensed Indication in the Territory. Celltech shall use its Commercially Reasonable Efforts to cause a pre-submission meeting to be held with the EMEA in respect of the cataplexy Licensed Indication within one hundred eighty (180) days of the Effective Date. Within thirty (30) days of such meeting with the EMEA, Celltech shall report to Orphan Medical about the content of such meeting and advise Orphan Medical as to whether additional data or documentation or additional action is required or deemed reasonably necessary by Celltech to obtain approval from the EMEA to commercially promote and distribute the Product for the cataplexy Licensed Indication. If additional data or documentation or additional action is required or deemed reasonably necessary by Celltech to obtain such approval and Orphan Medical has or could readily produce such data or documentation or take such additional action, Orphan Medical shall so provide the additional data or documentation or take the additional action at its sole cost and expense; provided, however, that in the event the cost of any single study or other report required by the EMEA or deemed reasonably necessary by Celltech shall exceed * or the aggregate cost of all studies or other reports required by the EMEA or deemed reasonably necessary by Celltech shall exceed *, Celltech and Orphan Medical shall meet and discuss in good faith the apportionment of such costs between them. Provided that Orphan Medical's NDA and other relevant Know How and related Proprietary Information are deemed reasonably sufficient by Celltech, Celltech shall, at its own expense, file the application for approval of the Product by the EMEA as an orphan drug.

Regulatory Timelines. (a) Within thirty (30) days of the Effective Date, Orphan Medical shall (i) transfer the Orphan Medical Drug Designation in the Territory from IDIS World Medicines to Celltech, and (ii) provide Celltech with the NDA and the Know How and the related Proprietary Information to enable Celltech to prepare and timely file the applications to commercially promote and distribute the Product for the cataplexy Licensed Indication in the Territory. Celltech shall use its Commercially Reasonable Efforts to cause a pre-submission meeting to be held with the EMEA in respect of the cataplexy Licensed Indication within one hundred eighty (180) days of the Effective Date. Within thirty (30) days of such meeting with the EMEA, Celltech shall report to Orphan Medical about the content of such meeting and advise Orphan Medical as to whether additional data or documentation or additional action is required or deemed reasonably necessary by Celltech to obtain approval from the EMEA to commercially promote and distribute the Product for the cataplexy Licensed Indication. If additional data or documentation or additional action is required or deemed reasonably necessary by Celltech to obtain such approval and Orphan Medical has or could readily produce such data or documentation or take such additional action, Orphan Medical shall so provide the additional data or documentation or take the additional action at its sole cost and expense; provided, however, that in the event the cost of any single study or other report required by the EMEA or deemed reasonably necessary by Celltech shall exceed * or the aggregate cost of all studies or other reports required by the EMEA or deemed reasonably necessary by Celltech shall exceed ** , Celltech and Orphan Medical shall meet and discuss in good faith the apportionment of such costs between them. Provided that Orphan Medical's ’s NDA and other relevant Know How and related Proprietary Information are deemed reasonably sufficient by Celltech, Celltech shall, at its own expense, file the application for approval of the Product by the EMEA as an orphan drug.

Regulatory Timelines. (a) Within thirty (30) days of the Effective Date, Orphan Medical shall (i) transfer the Orphan Medical Drug Designation in the Territory from IDIS World Medicines to Celltech, and (ii) provide Celltech with the NDA and the Know How and the related Proprietary Information to enable Celltech to prepare and timely file the applications to commercially promote and distribute the Product for the cataplexy Licensed Indication in the Territory. Celltech shall use its Commercially Reasonable Efforts to cause a pre-submission meeting to be held with the EMEA in respect of the cataplexy Licensed Indication within one hundred eighty (180) days of the Effective Date. Within thirty (30) days of such meeting with the EMEA, Celltech shall report to Orphan Medical about the content of such meeting and advise Orphan Medical as to whether additional data or documentation or additional action is required or deemed reasonably necessary by Celltech to obtain approval from the EMEA to commercially promote and distribute the Product for the cataplexy Licensed Indication. If additional data or documentation or additional action is required or deemed reasonably necessary by Celltech to obtain such approval and Orphan Medical has or could readily produce such data or documentation or take such additional action, Orphan Medical shall so provide the additional data or documentation or take the additional action at its sole cost and expense; provided, however, that in the event the cost of any single study or other report required by the EMEA or deemed reasonably necessary by Celltech shall exceed ** or the aggregate cost of all studies or other reports required by the EMEA or deemed reasonably necessary by Celltech shall exceed **, Celltech and Orphan Medical shall meet and discuss in good faith the apportionment of such costs between them. Provided that Orphan Medical's NDA and other relevant Know How and related Proprietary Information are deemed reasonably sufficient by Celltech, Celltech shall, at its own expense, file the application for approval of the Product by the EMEA as an orphan drug.

Regulatory Timelines. (a) Within thirty (30) days of the Effective Date, Orphan Medical shall (i) transfer the Orphan Medical Drug Designation in the Territory from IDIS World Medicines to Celltech, and (ii) provide Celltech with the NDA and the Know How and the related Proprietary Information to enable Celltech to prepare and timely file the applications to commercially promote and distribute the Product for the cataplexy Licensed Indication in the Territory. Celltech shall use its Commercially Reasonable Efforts to cause a pre-submission meeting to be held with the EMEA in respect of the cataplexy Licensed Indication within one hundred eighty (180) days of the Effective Date. Within thirty (30) days of such meeting with the EMEA, Celltech shall report to Orphan Medical about the content of such meeting and advise Orphan Medical as to whether additional data or documentation or additional action is required or deemed reasonably necessary by Celltech to obtain approval from the EMEA to commercially promote and distribute the Product for the cataplexy Licensed Indication. If additional data or documentation or additional action is required or deemed reasonably necessary by Celltech to obtain such approval and Orphan Medical has or could readily produce such data or documentation or take such additional action, Orphan Medical shall so provide the additional data or documentation or take the additional action at its sole cost and expense; provided, however, that in the event the cost of any single study or other report required by the EMEA or deemed reasonably necessary by Celltech shall exceed * or the aggregate cost of all studies or other reports required by the EMEA or deemed reasonably necessary by Celltech shall exceed *, Celltech and Orphan Medical shall meet and discuss in good faith the apportionment of such costs between them. Provided that Orphan Medical's ’s NDA and other relevant Know How and related Proprietary Information are deemed reasonably sufficient by Celltech, Celltech shall, at its own expense, file the application for approval of the Product by the EMEA as an orphan drug.