Transfer Authorizations. INSERM-TRANSFERT and INSERM agree that, subject to approval of the Informed Consent Form by the relevant regulatory authorities, they will include express language in such Informed Consent Form specifying that the Trial Subject authorizes transfer and use of his/her personal data contained in the Clinical Data to third parties located in countries outside the European Union, in particular the United States. Provided that INSERM, INSERM TRANSFERT and Investigator have used diligent efforts and acted in good faith to obtain signed Informed Consent Forms from Trial Subjects and regulatory approvals for the transfer to and use of Clinical Data by LICENSEE as contemplated herein, INSERM, INSERM TRANSFERT and/or Investigator cannot be held liable (i) in case the Trial Subjects (or their legal representatives) do not execute the Informed Consent Form and/or (ii) in case the prior regulatory authorization is not obtained for the transfer and use of the Clinical Data and/or in case, as a consequence of (i) or (ii), INSERM is not in the capacity to provide LICENSEE with Clinical Data. In such a case, this Amendment 2 shall be immediately terminated, without INSERM and/or INSERM TRANSFERT and/or Investigator being liable for any damages or other kind of compensation. For clarity, in such event, no Clinical Data Access Fees shall be due to INSERM and/or INSERM TRANSFERT from LICENSEE under Section 5.1.2.
Appears in 3 contracts
Sources: Patent and Know How License Agreement, Patent and Know How License Agreement (Bluebird Bio, Inc.), Patent and Know How License Agreement (Bluebird Bio, Inc.)