Common use of Akcea Cooperation Clause in Contracts

Akcea Cooperation. (a) At no cost to Novartis, on a Product-by-Product basis, within [***] ([***]) calendar days after Akcea grants Novartis the license for such Product under Section 5.1, Akcea will transfer the IND for such Product to Novartis together with all regulatory documentation (including pending drafts) related to such Product. (b) Following such IND transfer under Section 6.6.2(a), if requested by Novartis and mutually agreed by Akcea (such agreement not to be unreasonably withheld, delayed or conditioned), Akcea shall cooperate with and provide reasonable assistance to Novartis in connection with filings or submission to any Regulatory Authority relating to the Products, including by executing any required documents, providing access to personnel and providing Novartis with copies of all reasonably required documentation. After the first [***] hours of Akcea’s time for any assistance under this Section 6.6.2(b), Novartis will compensate Akcea in accordance with Section 7.10 for Akcea’s and its Affiliates’ * ***Confidential Treatment Requested activities conducted under this Section 6.6.2(b). To the extent required to submit a regulatory filing or submission to a Regulatory Authority, Akcea shall grant or cause to be granted to Novartis and its Affiliates or Sublicensees cross-reference rights to any relevant drug master files and other filings submitted by Akcea or its Affiliates with any Regulatory Authority

Akcea Cooperation. (a) At no cost to Novartis, on a Product-by-Product basis, within [***] ([***]) calendar days after Akcea grants Novartis the license for such Product under Section 5.1, Akcea will transfer the IND for such Product to Novartis together with all regulatory documentation (including pending drafts) related to such Product. (b) Following such IND transfer under Section 6.6.2(a), if requested by Novartis and mutually agreed by Akcea Xxxxx (such agreement not to be unreasonably withheld, delayed or conditioned), Akcea shall cooperate with and provide reasonable assistance to Novartis in connection with filings or submission to any Regulatory Authority relating to the Products, including by executing any required documents, providing access to personnel and providing Novartis with copies of all reasonably required documentation. After the first [***] hours of Akcea’s time for any assistance under this Section 6.6.2(b), Novartis will compensate Akcea in accordance with Section 7.10 for Akcea’s and its Affiliates’ * ***Confidential Treatment Requested 27 activities conducted under this Section 6.6.2(b). To the extent required to submit a regulatory filing or submission to a Regulatory Authority, Akcea shall grant or cause to be granted to Novartis and its Affiliates or Sublicensees cross-reference rights to any relevant drug master files and other filings submitted by Akcea or its Affiliates with any Regulatory Authority

Akcea Cooperation. (a) At no cost to Novartis, on a Product-by-Product basis, within [***] ([***]) calendar days after Akcea grants Novartis the license for such Product under Section 5.1, Akcea will transfer the IND for such Product to Novartis together with all regulatory documentation (including pending drafts) related to such Product.. Confidential (b) Following such IND transfer under Section 6.6.2(a), if requested by Novartis and mutually agreed by Akcea (such agreement not to be unreasonably withheld, delayed or conditioned), Akcea shall cooperate with and provide reasonable assistance to Novartis in connection with filings or submission to any Regulatory Authority relating to the Products, including by executing any required documents, providing access to personnel and providing Novartis with copies of all reasonably required documentation. After the first [***] hours of Akcea’s time for any assistance under this Section 6.6.2(b), Novartis will compensate Akcea in accordance with Section 7.10 for Akcea’s and its Affiliates’ * ***Confidential Treatment Requested activities conducted under this Section 6.6.2(b). To the extent required to submit a regulatory filing or submission to a Regulatory Authority, Akcea shall grant or cause to be granted to Novartis and its Affiliates or Sublicensees cross-reference rights to any relevant drug master files and other filings submitted by Akcea or its Affiliates with any Regulatory Authority