Common use of Delivery of the Draft Study Report and Final Study Report Clause in Contracts

Delivery of the Draft Study Report and Final Study Report. On a Product-by-Product basis, no later than [***] months before the anticipated Completion of the Phase 2 Dose-Ranging Trial, the Parties shall define and agree on the format and substantive content of the Draft Study Report and the Final Study Report in accordance with the ICH E3 industry guidelines for Structure and Content of Clinical Study Report. Notwithstanding the foregoing, it is understood and agreed that the Draft Study Report will include all [***], as well as all [***], [***] and [***] and any information related thereto, [***] and [***] generated from the [***] in sufficient detail so as to reasonably demonstrate whether [***] has been achieved in accordance with [***] and whether any [***] further development of a Product. Following Completion of the Phase 2 Dose-Ranging Trial, Akcea will use Commercially Reasonable Efforts to complete the Draft Study Report and Akcea shall deliver to Novartis such Draft Study Report within [***] ([***]) calendar days after the date on which such Draft Study Report becomes available (but no later than [***] months following Completion of such study). For a period of [***] ([***]) calendar days from and after the delivery of such Draft Study Report, Novartis shall have the right to request from Akcea such additional information then in the possession of or readily available to Akcea as Novartis may reasonably require regarding the Phase 2 Dose-Ranging Trial, and Akcea shall promptly provide or make available to Novartis any such * ***Confidential Treatment Requested additional information. Akcea will use Commercially Reasonable Efforts to complete the Final Study Report once Akcea has the data and other information necessary for such Final Study Report. Akcea shall deliver to Novartis such Final Study Report within [***] ([***]) calendar days after the date on which such Final Study Report is completed. For a period of [***] ([***]) calendar days from and after the delivery of such Final Study Report, Novartis shall have the right to request from Akcea such additional information then in the possession of or readily available to Akcea as Novartis may reasonably require regarding the Phase 2 Dose-Ranging Trial, and Akcea shall promptly provide or make available to Novartis any such additional information that Akcea has not previously delivered to Novartis. Furthermore, Akcea shall make available to Novartis through due diligence, information, data, and documents requested by Novartis in the possession of or readily available to Akcea generated between the Effective Date and the Final Study Report, relevant for Novartis.

Delivery of the Draft Study Report and Final Study Report. On a Product-by-Product basis, no later than [***] months before the anticipated Completion of the Phase 2 Dose-Ranging Trial, the Parties shall define and agree on the format and substantive content of the Draft Study Report and the Final Study Report in accordance with the ICH E3 industry guidelines for Structure and Content of Clinical Study Report. Notwithstanding the foregoing, it is understood and agreed that the Draft Study Report will include all [***], as well as all [***], [***] and [***] and any information related thereto, [***] and [***] generated from the [***] in sufficient detail so as to reasonably demonstrate whether [***] has been achieved in accordance with [***] and whether any [***] further development of a Product. Following Completion of the Phase 2 Dose-Ranging Trial, Akcea will use Commercially Reasonable Efforts to complete the Draft Study Report and Akcea shall deliver to Novartis such Draft Study Report within [***] ([***]) calendar days after the date on which such Draft Study Report becomes available (but no later than [***] months following Completion of such study). For a period of [***] ([***]) calendar days from and after the delivery of such Draft Study Report, Novartis shall have the right to request from Akcea such additional information then in the possession of or readily available to Akcea as Novartis may reasonably require regarding the Phase 2 Dose-Ranging Trial, and Akcea shall promptly provide or make available to Novartis any such * ***Confidential Treatment Requested additional information. Akcea will use Commercially Reasonable Efforts to complete the Final Study Report once Akcea has the data and other information necessary for such Final Study Report. Akcea shall deliver to Novartis such Final Study Report within [***] ([***]) calendar days after the date on which such Final Study Report is completed. For a period of [***] ([***]) calendar days from and after the delivery of such Final Study Report, Novartis shall have the right to request from Akcea such additional information then in the possession of or readily available to Akcea as Novartis may reasonably require regarding the Phase 2 Dose-Ranging Trial, and Akcea shall promptly provide or make available to Novartis any such additional information that Akcea has not previously delivered to Novartis. Furthermore, Akcea shall make available to Novartis through due diligence, information, data, and documents requested by Novartis in the possession of or readily available to Akcea generated between the Effective Date and the Final Study Report, relevant for Novartis.