Common use of Marketing Authorization Holder Clause in Contracts

Marketing Authorization Holder. Subject to Collegium’s obligations upon termination pursuant to Section 13.06, Collegium shall, upon assignment of the Current Product NDA to Collegium following Supplement Approval, be the holder and owner of all Marketing Authorizations and Governmental Approvals in the Territory concerning Licensed Products and responsible for all associated legal obligations with respect thereto, including but not limited to the performance of all obligations with respect to Licensed Products under the Transmucosal Immediate Release Fentanyl (“TIRF”) Risk Evaluation and Mitigation Strategy (“REMS”) program established by FDA. Collegium acknowledges and agrees that such responsibilities under such TIRF REMS program shall include appointing a Collegium representative on the relevant TIRF REMS working group established by the FDA or otherwise associated with such program and paying its portion of all fees, costs, and expenses imposed on, or incurred as, members of such group or otherwise imposed by FDA with respect to such program or group (“TIRF Fees”), and Collegium further agrees that it shall promptly reimburse BDSI for the portion of any TIRF Fees paid by BDSI after the Effective Date which correspond to any period of time during which Collegium is the holder of the Current Product NDA.