United States – Primary Indication. During the R&D Pre-Transfer Period, Atara shall be responsible, at Partner’s sole cost and expense in accordance with the Transition Budget, for all activities directed to obtaining Regulatory Approval (including the preparation and filing of all Regulatory Materials, including, without limitation, any BLA, and all Regulatory Interactions and site inspections) for the Product for the Primary Indication in the United States; provided, however, that Atara shall promptly submit to Partner all material correspondence received from a Regulatory Authority with respect to such Regulatory Approvals, as well as all relevant draft filings or draft material correspondence with the Regulatory Authorities with reasonable lead time, which shall not be less than [***] for correspondence with the FDA relating to negotiation of the Label, to allow Partner to comment on such drafts, and take into account Partner’s reasonable comments on such correspondence or filings. To the extent practical and without causing any undue delay, and to the extent permitted by the Regulatory Authority, Atara shall permit an appropriate representative of Partner to attend any meeting with Regulatory Authorities relating to filing or obtaining such Regulatory Approvals as a silent observer under Xxxxx’s supervision. Notwithstanding the foregoing, Atara will provide, at any time within [***] after Partner’s written request therefor, the right for Partner to assume sole responsibility for obtaining Regulatory Approval (including the preparation and filing of all Regulatory Materials, including, without limitation, any BLA, and all Regulatory Interactions) for the Product for the Primary Indication in the United States, and Atara shall transition to Partner all activities related thereto in accordance with a mutually agreed transition plan.
