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. (b) Following approval from the EMEA to commercially promote and distribute the Product for the cataplexy Licensed Indication, Celltech shall use Commercially Reasonable Efforts to obtain Registration of the Product for the cataplexy Licensed Indication (i) in the Major European Countries no later than December 31, 2005 (the “Registration Date”) and (ii) in the other countries in the Territory within such time frames as are consistent with the regulatory plan submitted by Celltech to Orphan Medical as provided in Section 3.1; unless, in any such case, additional data or documentation or additional action is required, in which case, the timeframe shall be extended by the time required to generate the additional data or documentation or take the additional action. Where a Regulatory Authority requires additional data or documentation or additional action that is not within Orphan Medical’s sole obligation as delineated in paragraph (a) above and that neither party has or could readily produce or which cannot readily be taken by either party, the parties shall negotiate in good faith the terms upon which such data or documentation should be generated or actions taken by either party, if at all, or failing agreement, to terminate this Agreement in so far as it relates to a country in the Territory not a member of the European Union or the European Free Trade Area. (c) Anything herein to the contrary notwithstanding, (i) except as provided in paragraphs (a) and (b) above, in connection with providing additional data and documentation or taking additional actions pursuant to this Section 3.2, each party shall be responsible for all costs and expenses of its respective employees, agents, contractors, sublicensees and subdistributors, and (ii) no party shall be obligated to conduct any clinical trials after the Effective Date. (d) Following the development by Orphan Medical of a supplemental NDA for the excessive daytime sleepiness Licensed Indication, which such supplemental NDA shall be developed by Orphan Medical as soon as practicable after the Effective Date, a copy thereof shall be delivered to Celltech to enable it to prepare an application to the EMEA for approval to commercially promote and distribute the Product in the Territory for the excessive daytime sleepiness Licensed Indication. Such application shall be filed by Celltech no later than the later of (i) issuance of the license to Celltech by the EMEA for the cataplexy Licensed Indication or (ii) one hundred eighty (180) days after Orphan Medical delivers such supplemental NDA to Celltech, unless additional data or documentation or additional action is required from Orphan Medical or a Third Party, in which case the one hundred eighty (180) days shall be extended by the time required to generate the additional data or documentation or take the additional action.

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. (b) Following approval from the EMEA to commercially promote and distribute the Product for the cataplexy Licensed Indication, Celltech shall use Commercially Reasonable Efforts to obtain Registration of the Product for the cataplexy Licensed Indication (i) in the Major European Countries no later than December 31, 2005 (the “Registration Date”"REGISTRATION DATE") and (ii) in the other countries in the Territory within such time frames as are consistent with the regulatory plan submitted by Celltech to Orphan Medical as provided in Section 3.1; unless, in any such case, additional data or documentation or additional action is required, in which case, the timeframe shall be extended by the time required to generate the additional data or documentation or take the additional action. Where a Regulatory Authority requires additional data or documentation or additional action that is not within Orphan Medical’s 's sole obligation as delineated in paragraph (a) above and that neither party has or could readily produce or which cannot readily be taken by either party, the parties shall negotiate in good faith the terms upon which such data or documentation should be generated or actions taken by either party, if at all, or failing agreement, to terminate this Agreement in so far as it relates to a country in the Territory not a member of the European Union or the European Free Trade Area. (c) Anything herein to the contrary notwithstanding, (i) except as provided in paragraphs (a) and (b) above, in connection with providing additional data and documentation or taking additional actions pursuant to this Section 3.2, each party shall be responsible for all costs and expenses of its respective employees, agents, contractors, sublicensees and subdistributors, and (ii) no party shall be obligated to conduct any clinical trials after the Effective Date. (d) Following the development by Orphan Medical of a supplemental NDA for the excessive daytime sleepiness Licensed Indication, which such supplemental NDA shall be developed by Orphan Medical as soon as practicable after the Effective Date, a copy thereof shall be delivered to Celltech to enable it to prepare an application to the EMEA for approval to commercially promote and distribute the Product in the Territory for the excessive daytime sleepiness Licensed Indication. Such application shall be filed by Celltech no later than the later of (i) issuance of the license to Celltech by the EMEA for the cataplexy Licensed Indication or (ii) one hundred eighty (180) days after Orphan Medical delivers such supplemental NDA to Celltech, unless additional data or documentation or additional action is required from Orphan Medical or a Third Party, in which case the one hundred eighty (180) days shall be extended by the time required to generate the additional data or documentation or take the additional action.

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. (b) Following approval from the EMEA to commercially promote and distribute the Product for the cataplexy Licensed Indication, Celltech shall use Commercially Reasonable Efforts to obtain Registration of the Product for the cataplexy Licensed Indication (i) in the Major European Countries no later than December 31, 2005 (the “Registration Date”) and (ii) in the other countries in the Territory within such time frames as are consistent with the regulatory plan submitted by Celltech to Orphan Medical as provided in Section 3.1; unless, in any such case, additional data or documentation or additional action is required, in which case, the timeframe shall be extended by the time required to generate the additional data or documentation or take the additional action. Where a Regulatory Authority requires additional data or documentation or additional action that is not within Orphan Medical’s sole obligation as delineated in paragraph (a) above and that neither party has or could readily produce or which cannot readily be taken by either party, the parties shall negotiate in good faith the terms upon which such data or documentation should be generated or actions taken by either party, if at all, or failing agreement, to terminate this Agreement in so far as it relates to a country in the Territory not a member of the European Union or the European Free Trade Area. (c) Anything herein to the contrary notwithstanding, (i) except as provided in paragraphs (a) and (b) above, in connection with providing additional data and documentation or taking additional actions pursuant to this Section 3.2, each party shall be responsible for all costs and expenses of its respective employees, agents, contractors, sublicensees and subdistributors, and (ii) no party shall be obligated to conduct any clinical trials after the Effective Date. (d) Following the development by Orphan Medical of a supplemental NDA for the excessive daytime sleepiness Licensed Indication, which such supplemental NDA shall be developed by Orphan Medical as soon as practicable after the Effective Date, a copy thereof shall be delivered to Celltech to enable it to prepare an application to the EMEA for approval to commercially promote and distribute the Product in the Territory for the excessive daytime sleepiness Licensed Indication. Such application shall be filed by Celltech no later than the later of (i) issuance of the license to Celltech by the EMEA for the cataplexy Licensed Indication or (ii) one hundred eighty (180) days after Orphan Medical delivers such supplemental NDA to Celltech, unless additional data or documentation or additional action is required from Orphan Medical or a Third Party, in which case the one hundred eighty (180) days shall be extended by the time required to generate the additional data or documentation or take the additional action.

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. (b) Following approval from the EMEA to commercially promote and distribute the Product for the cataplexy Licensed Indication, Celltech shall use Commercially Reasonable Efforts to obtain Registration of the Product for the cataplexy Licensed Indication (i) in the Major European Countries no later than December 31, 2005 (the “Registration Date”"REGISTRATION DATE") and (ii) in the other countries in the Territory within such time frames as are consistent with the regulatory plan submitted by Celltech to Orphan Medical as provided in Section 3.1; unless, in any such case, additional data or documentation or additional action is required, in which case, the timeframe shall be extended by the time required to generate the additional data or documentation or take the additional action. Where a Regulatory Authority requires additional data or documentation or additional action that is not within Orphan Medical’s 's sole obligation as delineated in paragraph (a) above and that neither party has or could readily produce or which cannot readily be taken by either party, the parties shall negotiate in good faith the terms upon which such data or documentation should be generated or actions taken by either party, if at all, or failing agreement, to terminate this Agreement in so far as it relates to a country in the Territory not a member of the European Union or the European Free Trade Area. (c) Anything herein to the contrary notwithstanding, (i) except as provided in paragraphs (a) and (b) above, in connection with providing additional data and documentation or taking additional actions pursuant to this Section 3.2, each party shall be responsible for all costs and expenses of its respective employees, agents, contractors, sublicensees and subdistributors, and (ii) no party shall be obligated to conduct any clinical trials after the Effective Date. (d) Following the development by Orphan Medical of a supplemental NDA for the excessive daytime sleepiness Licensed Indication, which such supplemental NDA shall be developed by Orphan Medical as soon as practicable after the Effective Date, a copy thereof shall be delivered to Celltech to enable it to prepare an application to the EMEA for approval to commercially promote and distribute the Product in the Territory for the excessive daytime sleepiness Licensed Indication. Such application shall be filed by Celltech no later than the later of (i) issuance of the license to Celltech by the EMEA for the cataplexy Licensed Indication or (ii) one hundred eighty (180) days after Orphan Medical delivers such supplemental NDA to Celltech, unless additional data or documentation or additional action is required from Orphan Medical or a Third Party, in which case the one hundred eighty (180) days shall be extended by the time required to generate the additional data or documentation or take the additional action.