NDA Submission definition
Examples of NDA Submission in a sentence
This Agreement (and the attached Addenda A and B) constitutes the complete and exclusive statement of the terms and conditions between the parties, and supersedes and merges all prior proposals, understandings and all other agreements, oral and written, between the parties relating to the subject matter of this Agreement.
KHK shall give DICERNA written notice of its intent to submit an NDA to the FDA with respect to each Licensed Product for the Initial Target at least [***] prior to the anticipated date of such submission (each, an “NDA Submission Notice”), which NDA Submission Notice shall include a written report setting forth in reasonable detail all Development Costs incurred by KHK with respect to such Licensed Product through the date of the NDA Submission Notice.
Matrix shall provide to HMR within one (1) month of HMR's request, copies of all regulatory correspondence, including, but not limited to, IND Information Amendments, IND Reports, IND Safety Reports, NDA Submission, NDA Post-marketing Reports, and reports of written/phone contacts to/from regulatory agencies, as well as the safety database (as applicable).
The principal amount of the NDA Submission Note shall be due and payable on the earlier to occur of either (a) five (5) business days following the consummation of a public offering by OraPharma of equity securities registered under the Securities Act of 1933 (as amended), if any, after the date of the NDA Submission Note, or (b) the date that is three (3) years following the date of the NDA Submission Note.
ACY shall also be entitled to receive warrants to purchase One Hundred Twenty Five Thousand Dollars ($125,000) of OraPharma Stock based upon the OraPharma Stock FMV as of such NDA Submission Achievement Date (the "Option 1 Warrants").
The number of shares of OraPharma Stock that ACY may purchase upon the exercise of the Option 1 Warrants shall be equal to the result of $125,000 divided by the ---------- OraPharma Stock FMV on such NDA Submission Achievement Date.
If ViaCell proceeds to NDA Submission without having made the Milestone Payment for milestone "a" (Commencement of Phase III Clinical Trial), e.g., because the data from a Phase II clinical trial is believed to be sufficient for registration, then such Milestone Payment for milestone "a" shall be made concurrently with the Milestone Payment for Milestone "b" (NDA Submission).
Interest shall accrue thereon at a fluctuating rate per annum equal to the prime rate of CitiBank, N.A. (or any successor thereto) in effect on the first business day of each calendar quarter, and shall be due and payable in arrears on the last business day of each calendar quarter during the term of the NDA Submission Note, with a final interest payment due and payable on the maturity date.
The ----------------- Option 1 Warrants shall be non-transferrable and may be exercised at any time during a period of five (5) years following the date of issuance thereof at a price equal to the OraPharma Stock FMV on such NDA Submission Achievement Date.
Start of a Pivotal Trial in the U.S. $6.3 MM NDA Submission to FDA $12.6 MM NDA Approval by FDA $23.1 MM ------------------- -------- Total $42.0 MM Category Three Indications - If a Category Three indication is the first indication for a Licensed Product, the Category Three Milestones will be paid in the amounts set forth below upon the first occurrence of the events set forth below.