Filing of NDA Sample Clauses

Filing of NDA. Licensee will notify GenuPro, in writing, within fourteen (14) days of the first acceptance by the FDA of a filing of an NDA for the use of a Licensed Product in the Field in the U.S. Within thirty (30) days of such acceptance, Licensee will pay GenuPro a one-time milestone payment of [*] if such acceptance occurs on or before [*], or [*] if such acceptance occurs after [*].
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Filing of NDA. During the Certification Period, Horizon shall be responsible for the preparation of all documentation necessary for the filing of an NDA for the Designated Product and shall file such NDA. Each party understands and agrees that the other does not warrant or commit that the Designated Product will be successfully certified for marketing by the FDA, and neither party shall have any liability or responsibility to the other or to third parties for any such failure of the certification process hereunder, except to the extent such failure results from said party's intentional misconduct, gross negligence, or material breach of its duties or obligations as set forth herein.
Filing of NDA. During the Certification Period, Horizon shall be responsible for the preparation of all documentation necessary for the filing of an NDA for the Designated Product and shall file such NDA. Each party understands and agrees that the other does not warrant or commit that the Designated Product will be successfully certified for marketing by the FDA, and neither party shall have any liability or responsibility to the other or to third parties for any such failure of the certification process hereunder, except to the extent such failure results from said party's intentional misconduct, gross negligence, or material breach of its duties or obligations as set forth herein. 11 [***] - CONFIDENTIAL TREATMENT REQUESTED

Related to Filing of NDA

  • Filing of Agreement The Parties acknowledge that either or both Parties may be obligated under the disclosure requirements of an Exchange to file a copy of this Agreement with such Exchange. Each Party shall be entitled to make such a required filing, provided that it uses reasonable efforts to request confidential treatment of the commercial terms and sensitive technical terms of this Agreement, to the extent such confidential treatment is reasonably available to such Party. The filing Party shall provide to the other Party a copy of this Agreement marked to show the provisions for which the filing Party intends to seek confidential treatment no less than [***] before the date of the proposed filing, for such other Party’s review and comment, [***].

  • Filing of a Form 8-A The Company has filed with the Commission a Form 8-A (file number 001-[__]) providing for the registration under the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder (collectively, the “Exchange Act”) of certain of the securities of the Company, which registration is currently effective on the date hereof.

  • Filing of Motions Until the First Priority Obligations Payment Date has occurred, the Second Priority Representative agrees on behalf of itself and the other Second Priority Secured Parties that no Second Priority Secured Party shall, in or in connection with any Insolvency Proceeding, file any pleadings or motions, take any position at any hearing or proceeding of any nature, or otherwise take any action whatsoever, in each case that (a) violates, or is prohibited by, this Section 5 (or, in the absence of an Insolvency Proceeding, otherwise would violate or be prohibited by this Agreement), (b) asserts any right, benefit or privilege that arises in favor of the Second Priority Secured Parties, in whole or in part, as a result of their interest in the Common Collateral (unless the assertion of such right is expressly permitted by this Agreement) or (c) challenges the validity, priority, enforceability or voidability of any Liens or claims held by the First Priority Representative or any other First Priority Secured Party with respect to the Common Collateral, or the extent to which the First Priority Obligations constitute secured claims or the value thereof under Section 506(a) of the Bankruptcy Code or otherwise; provided that the Second Priority Representative may (i) file a proof of claim in an Insolvency Proceeding and (ii) file any necessary responsive or defensive pleadings in opposition to any motion or other pleadings made by any Person objecting to or otherwise seeking the disallowance of any claims of the Second Priority Secured Parties on the Common Collateral, subject to the limitations contained in this Agreement and only if consistent with the terms and the limitations on the Second Priority Representative imposed hereby.

  • Filing of Reports Title Company shall be solely responsible for the timely filing of any reports or returns required pursuant to the provisions of Section 6045(e) of the Internal Revenue Code of 1986 (and any similar reports or returns required under any state or local laws) in connection with the closing of the transaction contemplated in this Agreement.

  • Filing of Amendments 9 (c) Delivery of Registration Statements......................... 9 (d) Delivery of Prospectus...................................... 10 (e) Continued Compliance with Securities Laws................... 10 (f) Blue Sky Qualifications..................................... 10 (g) Rule 158.................................................... 10 (h) Use of Proceeds............................................. 11 (i) Subchapter M................................................ 11 (j) Listing..................................................... 11 (k) Restrictions on Sale of Shares.............................. 11

  • Filing of Returns The parties agree that, unless required by the tax authorities, the Depositor, on behalf of the Issuer, will file or cause to be filed annual or other returns, reports and other forms consistent with the characterizations described in Section 2.11(a) and the first sentence of Section 2.11(b).

  • Filing of Form 8-K On or before the date which is four (4) Trading Days after the Execution Date, the Company shall file a Current Report on Form 8-K with the SEC describing the terms of the transaction contemplated by the Registered Offering Transaction Documents in the form required by the 1934 Act, if such filing is required.

  • Filing of Patent Applications Each Party will make timely decisions regarding the filing of Patent Applications on the CRADA Subject Inventions made solely by its employee(s), and will notify the other Party in advance of filing. Collaborator will have the first opportunity to file a Patent Application on joint CRADA Subject Inventions and will notify PHS of its decision within sixty (60) days of an Invention being reported or at least thirty (30) days before any patent filing deadline, whichever occurs sooner. If Collaborator fails to notify PHS of its decision within that time period or notifies PHS of its decision not to file a Patent Application, then PHS has the right to file a Patent Application on the joint CRADA Subject Invention. Neither Party will be obligated to file a Patent Application. Collaborator will place the following statement in any Patent Application it files on a CRADA Subject Invention: “This invention was created in the performance of a Cooperative Research and Development Agreement with the National Institutes of Health, an Agency of the Department of Health and Human Services. The Government of the United States has certain rights in this invention.” If either Party files a Patent Application on a joint CRADA Subject Invention, then the filing Party will include a statement within the Patent Application that clearly identifies the Parties and states that the joint CRADA Subject Invention was made under this CRADA.

  • Filing of a Registration Statement The Company shall prepare and file with the SEC a Registration Statement, or multiple Registration Statements for the resale by the Investor of the Registrable Securities. The Company in its sole discretion may choose when to file such Registration Statements; provided, however, that the Company shall not have the ability to request any Advances until the effectiveness of a Registration Statement.

  • Filing of Registration Statement The Company has filed with the Commission a registration statement, and an amendment or amendments thereto, on Form F-1 (File No. 333-234654), including any related prospectus or prospectuses, for the registration of the Securities under the Securities Act, which registration statement and amendment or amendments have been prepared by the Company in conformity with the requirements of the Securities Act. Except as the context may otherwise require, such registration statement, as amended, on file with the Commission at the time the registration statement became effective (including the Preliminary Prospectus included in the registration statement, financial statements, schedules, exhibits and all other documents filed as a part thereof or incorporated therein and all information deemed to be a part thereof as of the Effective Date pursuant to paragraph (b) of Rule 430A of the Securities Act (the “Rule 430A Information”), is referred to herein as the “Registration Statement.” If the Company files any registration statement pursuant to Rule 462(b) of the Securities Act, then after such filing, the term “Registration Statement” shall include such registration statement filed pursuant to Rule 462(b). The Registration Statement has been declared effective by the Commission on the date hereof. Each prospectus used prior to the effectiveness of the Registration Statement, and each prospectus that omitted the Rule 430A Information that was used after such effectiveness and prior to the execution and delivery of this Agreement, is herein called a “Preliminary Prospectus.” The Preliminary Prospectus, subject to completion and filed with the Commission on [●], 2020, that was included in the Registration Statement immediately prior to the Applicable Time (as defined below) is hereinafter called the “Pricing Prospectus.” The final prospectus in the form first furnished to the Underwriters for use in the Offering is hereinafter called the “Prospectus.” Any reference to the “most recent Preliminary Prospectus” shall be deemed to refer to the latest Preliminary Prospectus included in the Registration Statement. For purposes of this Agreement:

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