Common use of Initial Marketing Authorization Clause in Contracts

Initial Marketing Authorization. (a) The Parties acknowledge that a notice of compliance (“NOC”) with respect to the Current Product NDS was issued to Paladin (the “NOC Filer”) on June 21, 2017. (b) BDSI shall use its best efforts to cause a transfer of such Marketing Authorization in the Territory to Purdue as soon as reasonably possible following the Effective Date, including, within *** business days of the Effective Date, causing the NOC Filer to submit the Endo Health Canada Letter to Health Canada. BDSI shall notify Purdue of any correspondence it receives with respect to the Current Product NDS within *** business days following its receipt by BDSI. BDSI acknowledges and agrees that, subject to Section 2.01(d), BDSI shall be responsible for all costs and expenses it incurs in connection with its performance of its obligations under this Section 2.01. (c) Purdue shall use its best efforts to file, with the Competent Authority, an administrative new drug submission for the Licensed Product (an “Administrative NDS”) to transfer from the NOC Filer to Purdue the DINs as soon as reasonably possible after the NOC Filer’s submission of the Endo Health Canada Letter to Health Canada, and in any case within *** days after the labeling information required to complete the Administrative NDS is prepared and approved by Purdue and BDSI, such approval in either case not to be unreasonably withheld, and Purdue shall thereafter use its best efforts to cause, as soon as reasonably possible, the grant of a NOC, and transfer and re-assignment of the DINs, to Purdue. BDSI shall use (i) its best efforts to cause the NOC Filer to take all reasonable actions necessary to initiate the transfer of the DINs to Purdue, including causing the NOC Filer to provide a letter to the Competent Authority in the appropriate form authorizing the Competent Authority to transfer the DINs issued to the NOC Filer, with such transfer to take effect as soon as reasonably possible thereafter and (ii) Commercially Reasonable Efforts to provide reasonable assistance to Purdue to file at the Competent Authority its Administrative NDS. (d) Purdue shall reimburse BDSI ***. (e) In the event any Governmental Authority in the Territory explicitly requires, as evidenced by written communication therefrom, ***.