Regulatory Approval Transition Protocol. Pending transfer from Axsome to Licensee (or to its Affiliates or Sublicensees) of each Transferred Regulatory Approval, the Parties shall cooperate in accordance with the Regulatory Approval Transition Protocol set forth in [Schedule 2.5.2].
Maintenance of Regulatory Approval. AYTU shall be responsible for all fees in connection with the transfer of a Product NDA (whether arising prior to or upon such transfer and whether relating to Tuzistra XR or CCP-08), including fees arising in connection with additional documents required to be filed prior to, in anticipation of or upon transfer of the NDA. AYTU shall be responsible for the PDUFA Program Fee for the 2019 FDA Fiscal Year and for the PDUFA Program Fees for all subsequent FDA Fiscal Years during the Term, it being understood that such PDUFA Program Fee for the 2019 FDA Fiscal Year has been paid by TRIS with respect to Tuzistra XR and as a result AYTU shall pay the same to TRIS on the Effective Date. Following such transfer of ownership of a Product NDA (whether relating to Tuzistra XR or CCP-08), AYTU shall during the Term of a Product, at its sole expense, be responsible for maintaining and shall use Commercially Reasonable Efforts to maintain the NDA for such Product (other than the DMFs with respect thereto), including the filing of all annual and other reports or filings required by the FDA or any other Governmental Authority, the performance and submission of stability studies on batches of such Product as may be required under FDA regulations (it being understood that such studies will be conducted by TRIS) and the preparation and filing of any notices, amendments or supplements as may be required to change or add another source of supply of the APIs for such Product and the payment of PDUFA Program Fees (in addition to the 2019 PDUFA Program Fee as aforesaid) and all other fees payable to the FDA (other than the PDUFA submission/application fee for CCP-08). To the extent not already held by TRIS, AYTU shall promptly provide TRIS (other than with respect to pharmacovigilance which will be governed by Section 2.4 and the Safety Data Exchange Agreement contemplated therein) with complete copies of all applications, submissions, filings and regulatory correspondence to or from the FDA or other Regulatory Authority relating to a Product. AYTU will file and maintain the Product drug listing under its labeler code and will submit all marketing materials to OPDP (formerly DDMAC) with a copy to TRIS. For the avoidance of doubt all post-marketing clinical trials and commitments with respect to Products shall be the sole responsibility, and at the sole cost and expense of AYTU. Notwithstanding anything to the contrary contained in this Agreement, changes to a Product NDA that relate in any respect to the information in TRIS’ DMF, as the same may be amended, shall be made solely as directed by TRIS and AYTU agrees to promptly make such changes and associated FDA filings as directed by TRIS. For the avoidance of doubt, if changes made or proposed to be made by TRIS in its DMF relating to CMC for a Product, are also required to be reflected in other parts of the NDA, or otherwise reported to the FDA, then AYTU will make such filings in the form and on the timetable requested by TRIS, at AYTU’s expense.
Approval. This Agreement is subject to prior review and approval of the Compensation Committee of the Companys Board.
Servicer Approval. [[Organization C:Organization]] shall not cause the Mortgage Loans to be serviced by any servicer other than a servicer expressly approved in writing by [[Organization B:Organization]], which approval shall be deemed granted by [[Organization B:Organization]] with respect to [[Organization C:Organization]] and Cenlar FSB with the execution of this Agreement.
Board Approval. The board of directors of the Company (the “Company Board”) (including any required committee or subgroup thereof), by resolutions duly adopted, has # determined that this Agreement and the Transactions are advisable and in the best interest of the Company and the Company Stockholders, # approved this Agreement and the Transactions in accordance with the Company Certificate of Incorporation and declared their advisability, and # resolved to recommend that the stockholders of the Company approve and adopt each of the matters requiring Company Stockholder Approval and directed that this Agreement and the Transactions be submitted for consideration by the Company Stockholders in accordance with Section 5.16.
Extension Approval. The Extension Approval shall have been obtained.
Shareholder Approval. The Company will obtain shareholder approval of any Plan amendment to the extent necessary and desirable to comply with Applicable Laws.
The Plan will be subject to approval by the shareholders of the Company within twelve (12) months after the date the Plan is adopted by the Board. Such shareholder approval will be obtained in the manner and to the degree required under Applicable Laws.
Stockholder Approval. Eastside will use commercially reasonable efforts to obtain from its stockholders as soon as possible following the date hereof such approval as is required by applicable law and/or rules of the Trading Market to effect all material terms of this Agreement (the “Stockholder Approval”), including without limitation approval to amend its articles of incorporation to increase its authorized Common Stock to a number of shares that equals or exceeds ten million (10,000,000) shares.
Board Approval. Each Party shall cause each Director that it has appointed pursuant hereto to vote to approve any transfer of Securities that complies with the terms of this Section 8.
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