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 Approval of a JNDA by the Koseisho 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. Portions of this Exhibit, indicated by the xxxx “[***],” 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.
Sample 1
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.
Sample 1

Related to JNDA Approval

  • 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 any and all approvals (including any applicable Pricing Approvals), licenses, registrations, or authorizations of any government agency or authority that are necessary for the marketing and sale of a Licensed Product in the relevant country or group of countries in the Territory.

  • CFIUS Approval means (a) CFIUS has concluded that the Transaction is not a “covered transaction” and not subject to review under the DPA, (b) CFIUS has issued a written notice that it has completed a review or investigation of the notification voluntarily provided pursuant to the DPA with respect to the Transaction, and has concluded all action under the DPA without imposing a Burdensome Condition or (c) if CFIUS has sent a report to the President of the United States requesting the President’s decision and (i) the President has announced a decision not to take any action to suspend or prohibit the Transaction or (ii) having received a report from CFIUS requesting the President’s decision, the President has not taken any action after fifteen (15) days from the earlier of the date the President received such report from CFIUS or the end of the investigation period.

  • CPUC Approval means a final and non-appealable order of the CPUC, without conditions or modifications unacceptable to the Parties, or either of them, which contains the following terms:

  • Development approval means a document from a governmental entity which authorizes the commencement of a development.

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Licensed Product in a country.