Examples of Major Market in a sentence
Opthea will oversee the manufacture of the Product for each Major Market Country, and will comply (and require that all Permitted Third Parties of Opthea comply) in all material respects with all Applicable Laws with respect to the research, development, manufacture, testing, analysis, labeling, storage, handling, disposal, transfer and use of the Product in each Major Market Country.
At each JSC meeting Opthea will provide material updates on the progress of the Product Clinical Trials and will report on material matters with respect to the progress toward obtaining Regulatory Approvals in the U.S., EU (if the EMA’s centralized procedure is to be used, and otherwise the non-U.S. and non-U.K. Major Market Countries) and UK.
Upon achievement of the Phase 3 Success Criteria, Opthea will (a) file a BLA for the Product in the Indication in the U.S. within [***] thereafter and (b) otherwise use Commercially Reasonable Efforts to obtain Regulatory Approval for the Product in the Indication in the U.S. and, until achievement of Regulatory Approval in the U.S., in the European Union (or, if EMA’s centralized review procedure is not used, at least one (1) additional non-U.S. Major Market Country).
Timely performance of the Product Clinical Trials and receipt of Regulatory Approval in the U.S. and, until achievement of Regulatory Approval in the U.S., in the European Union (or, if EMA’s centralized review procedure is not used, at least one (1) additional non-U.S. Major Market Country) are important to the success of this Agreement.