Obligation to Submit MA; Conditions to Submission Sample Clauses

Obligation to Submit MA; Conditions to Submission. Subject to Subsection 4.1.10 below with respect to Japan, promptly after the conclusion of the Phase III Trial and the completion of the tasks necessary for MA submission under the Initial or the then current Development Plan, as the case may be, TILLOTTS has the right and the obligation, at its expense, to prepare and file MAs, based on CPP´s prepared eCTD (or equivalent as is acceptable to TILLOTTS), and to obtain MA Approval in regard to the Licensed Formulation and the Primary Indication in the countries of the Licensed Territory. TILLOTTS must exercise Commercially Reasonable Diligence in prosecuting and obtaining MA Approvals based on its MA submission, file all necessary reports, and timely and fully respond to any requests by Regulatory Authorities in connection with those submissions and their review. TILLOTTS must exhaust all administrative remedies reasonably available (it being understood that litigation or other adversarial proceedings are not reasonably available remedies) in instances of adverse action by the EMA. TILLOTTS may elect not to submit an MA for the Licensed Formulation in the Licensed Territory if the JSC opines that the results of the Phase III Trial do not suggest that MA Approval is reasonably possible. Subject to Subsection 4.1.10 below with respect to Japan, either party may request that the filing of the MA in the Licensed Territory be deferred if: (i) the party requesting deferral demonstrates to the other party’s reasonable satisfaction that because of changes in regulatory requirements since the date of the conclusion of the Phase III Trial, the prospects for obtaining MA Approval or favorable pricing decisions from the applicable Regulatory Authorities would substantially improve by a deferral in the date of that submission; or (ii) the party requesting deferral demonstrates to the other party’s reasonable satisfaction that it is necessary to conduct additional studies to obtain MA Approval of the Licensed Formulation in the Licensed Territory, in which event the parties must promptly commence good faith discussions to inform each other regarding the need and purposes of those studies and to develop and agree upon a protocol to govern them and the parties’ respective obligations for paying for them, it being understood that neither party is obligated to agree upon the protocol or to pay for or contribution to the cost of those additional studies. Notwithstanding TILLOTTS’ election not to submit an MA based on the JSC’s ...
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Related to Obligation to Submit MA; Conditions to Submission

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