JNDA Approval definition

JNDA Approval means the Approval of a JNDA by the Koseisho (i.e., the Japanese Ministry of Health and Welfare, or any successor agency thereto) for the applicable Product in Japan.
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JNDA Approval shall be achieved upon receiving Regulatory Approval of a JNDA by the MHLW and, where applicable, receipt of pricing and reimbursement approvals, for the applicable Product in Japan.
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JNDA Approval means, with respect to a Product, receipt of Regulatory Approval of a JNDA by the MHLW and receipt of pricing and reimbursement approvals, for such Product in Japan.
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Examples of JNDA Approval in a sentence

  • U.S. NDA Filing US$ [***] U.S. NDA Approval HoFH US$ [***] U.S. NDA Approval HeFH US$ [***] MAA Approval for FH US$ [***] U.S. NDA Approval US$ [***] MAA Approval US$ [***] JNDA Approval US$ [***] Aggregate Milestones US$ [***] The parties will mutually agree on development and regulatory strategy and allocation of milestones based on various regulatory approvals.

  • Following the first JNDA filing for Final Product, BMKK and MJ shall coordinate the provision of the initial Final Product-specific sales training to their respective Sales Representatives and sales trainers for a period of [**] following such JNDA Approval (the “Initial Training Period”).


More Definitions of JNDA Approval

JNDA Approval means the final approval of a JNDA by the Koseisho for the applicable Licensed Product in Japan. Portions of this Exhibit, indicated by the ▇▇▇▇ “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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JNDA Approval means the final approval of a JNDA by the Koseisho for the applicable Licensed Product in Japan. Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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JNDA Approval means the Approval of a JNDA by the Koseisho ( i.e., the Japanese Ministry of Health and Welfare, or any successor agency thereto) for the applicable Product in Japan.
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JNDA Approval means the final approval of a JNDA by the Koseisho for the applicable Licensed Product in Japan.
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Related to JNDA Approval

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • FDA Approval means the approval of the United States Food and Drug Administration necessary for the marketing, distribution in interstate commerce and sale of the Initial Product (as defined in the Collaboration and License Agreement) in the United States.

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • Regulatory Approval means, with respect to the Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization that is required by the applicable Regulatory Authority to market and sell the Product in such country or jurisdiction.

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).