Common use of Safety Database Clause in Contracts

Safety Database. To the extent collected by Novartis and in the form in which Novartis stores such information for its own purposes, Novartis will provide Akcea with information concerning toxicology, pharmacokinetics, safety pharmacology study(ies) and adverse events related to Products licensed by Novartis under this Agreement within a reasonable period of time (but not later than [***] ([***]) calendar days after Novartis’ receipt of such information). In connection with any reported serious adverse event, Novartis will provide Akcea all serious adverse event reports within a reasonable time period of time but not later than [***] ([***]) calendar days after Novartis’ receipt of such information. In addition, with respect to Products, Novartis will provide Akcea with copies of Annual safety updates filed with each IND (e.g. DSURs or IND annual reports) and the safety sections of any final Clinical Study reports within [***] ([***]) calendar days following the date such information is filed, as applicable. Furthermore, Novartis will provide in a timely manner to Akcea supporting data that Novartis determines to be reasonably related to such safety information provided by Novartis under this Section 6.8(a) and answer in a timely manner any follow-up questions reasonably requested by Akcea or its Affiliates to the extent such data and answers are reasonably available to Novartis. All such information disclosed by Novartis to Akcea will be Novartis Confidential Information and Novartis acknowledges and agrees that Akcea will provide all such information to Ionis to enable Ionis to populate the Ionis Internal ASO Safety Database. In addition, so long as Akcea does not disclose the identity of a Product or Novartis’ identity, Akcea may disclose any such Novartis Confidential Information to (i) Akcea’s other partners pursuant to Section 6.8(c) below if such information is regarding class generic properties of ASOs, (ii) any Third Party (other than a Regulatory Authority) that contributes to the populating of the Ionis Internal ASO Safety Database, or (iii) a Regulatory Authority. Novartis will deliver all such information to Akcea for the Ionis Internal ASO Safety Database to Akcea Therapeutics, Inc., ▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇, Attention: Chief Medical Officer (or to such other address/contact designated in writing by Akcea). Novartis will also cause its Affiliates and Sublicensees to comply with this Section 6.8(b).