Common use of Holder of Regulatory Approvals and Regulatory Submissions Clause in Contracts

Holder of Regulatory Approvals and Regulatory Submissions. As between the Parties, Jazz shall be the holder of Regulatory Approvals and Regulatory Submission for Licensed Products in the Field in the Territory, except as expressly set forth in Section 5.2(b) with respect to the Zymeworks Ongoing Studies or in Section 6.2(b) with respect to the First BLA. At Jazz’s reasonable request [***], Zymeworks shall cooperate with Jazz to enable Jazz to obtain any or all such Regulatory Approvals and Regulatory Submissions.

Holder of Regulatory Approvals and Regulatory Submissions. As between the Parties, Jazz shall be the holder of Regulatory Approvals and Regulatory Submission for Licensed Products in the Field in the Territory, except as expressly set forth . The Parties acknowledge that all INDs for the use of Licensed Product in Section 5.2(b) with respect to the Zymeworks Ongoing Studies or and Zymeworks Korean Studies that are in Section 6.2(b) with respect existence as of the Amendment Effective Date will be transferred to Jazz pursuant to the First BLAPurchase Agreement. At Jazz’s reasonable request [***], Zymeworks shall cooperate with Jazz to enable Jazz to obtain any or all such Regulatory Approvals and Regulatory Submissions.