Maintenance of Regulatory Approval Sample Clauses

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 rel...
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Maintenance of Regulatory Approval. Heska shall be solely responsible for all costs, filings, studies or other actions required to obtain and maintain regulatory approval allowing for the sale and distribution of the Product in the Territory during the period of time that Heska is the exclusive supplier of Schering's requirements for the Product. Schering shall provide reasonable, non-financial assistance as requested by Heska for such purpose.
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Maintenance of Regulatory Approval. The Licensor shall use Commercially Reasonable Efforts to obtain and maintain the Regulatory Approval for the Product in the United States during the Term in compliance with the Applicable Law. If any change to the Product or the Regulatory Approval in the United States or any procedure performed with the Regulatory Agency in the United States may, to the Licensor's Knowledge, result in a change to the Regulatory Approval in a jurisdiction within the Territory or result in a procedure needing to be performed with the Regulatory Agency within the Territory, the Licensor shall serve NT Pharma an appropriate prior notice about the intended change before implementation and shall give reasonable consideration to the suggestion or objection raised by NT Pharma.
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Related to Maintenance of Regulatory Approval

  • No Regulatory Approval By the Company or Parent, if its Board of Directors so determines by a vote of a majority of the members of its entire Board, in the event any Requisite Regulatory Approval shall have been denied by final, nonappealable action by such Governmental Authority or a Governmental Authority shall have requested the permanent withdrawal of an application therefor.

  • Required Regulatory Approvals Certain transactions required, permitted or otherwise contemplated by this Agreement may under certain circumstances require prior filings with and approvals, or non-disapprovals, from the Indiana Department of Insurance or the Indiana Insurance Commissioner. Such transactions include: (a) issuance or purchase of any additional capital stock of the Company or other securities convertible into or exchangeable or exercisable for capital stock of the Company pursuant to Sections 1.2 or 3.4; (b) transfer of Shares to a wholly owned subsidiary of a Shareholder, to another Shareholder or to a wholly owned subsidiary of another Shareholder pursuant to Sections 3.1(a) or 3.4; (c) exercise of preemptive rights by a Shareholder pursuant to Section 3.2; and (d) exercise of call rights by the Company or a Shareholder pursuant to Section 3.3 (including pursuant to the two provisos in Section 3.1(b)). Notwithstanding anything to the contrary contained in this Agreement, any such transactions requiring filings with and approvals, or non-disapprovals, from the Indiana Department of Insurance or the Indiana Insurance Commissioner shall not, to the extent within the control of a party hereto, be entered into or consummated unless and until the required filings have been made and the required approvals (or non-disapprovals) have been obtained, and to the extent not within the control of an applicable party hereto, such party shall use best efforts to cause such transactions not to be entered into or consummated unless and until the required filings have been made and the required approvals (or non-disapprovals) have been obtained.

  • Regulatory Approval 25.1 The Parties understand and agree that this Agreement and any amendment or modification hereto will be filed with the Commission for approval in accordance with Section 252 of the Act and may thereafter be filed with the FCC. The Parties believe in good faith and agree that the services to be provided under this Agreement are in the public interest. Each Party covenants and agrees to fully support approval of this Agreement by the Commission or the FCC under Section 252 of the Act without modification.

  • Regulatory Approvals All Requisite Regulatory Approvals shall have been obtained and shall remain in full force and effect and all statutory waiting periods in respect thereof shall have expired, and no such Requisite Regulatory Approval shall have resulted in the imposition of any Materially Burdensome Regulatory Condition.

  • Requisite Regulatory Approvals All Consents required to be obtained from or made with any Governmental Authority in order to consummate the transactions contemplated by this Agreement shall have been obtained or made.

  • Maintenance of Approvals: Filings, Etc The Fund shall at all times maintain in effect, renew and comply with all the terms and conditions of all consents, filings, licenses, approvals and authorizations as may be necessary under any applicable law or regulation for its execution, delivery and performance of this Agreement and the other Related Documents to which it is a party.

  • Regulatory Approvals; Efforts (a) Prior to the Closing, Parent, Merger Sub and the Company shall use their respective reasonable best efforts to take, or cause to be taken, all actions, and to do, or cause to be done, all things necessary, proper or advisable under any applicable Laws to consummate and make effective the Merger including (i) the preparation and filing of all forms, registrations and notices required to be filed to consummate the Merger, (ii) the satisfaction of the conditions to consummating the Merger, (iii) taking all reasonable actions necessary to obtain (and cooperating with each other in obtaining) any consent, authorization, Order or approval of, or any exemption by, any third party, including any Governmental Entity (which actions shall include furnishing all information and documentary material required under the HSR Act) required to be obtained or made by Parent, Merger Sub, the Company or any of their respective Subsidiaries in connection with the Merger or the taking of any action contemplated by this Agreement, and (iv) the execution and delivery of any additional instruments necessary to consummate the Merger and to fully carry out the purposes of this Agreement. Additionally, each of Parent, Merger Sub and the Company shall use reasonable best efforts to fulfill all conditions precedent to the Merger and shall not take any action after the date of this Agreement that would reasonably be expected to materially delay the obtaining of, or result in not obtaining, any permission, approval or consent from any such Governmental Entity necessary to be obtained prior to Closing. To the extent that transfers of any permits issued by any Governmental Entity are required as a result of the execution of this Agreement or the consummation of the Merger, the parties hereto shall use reasonable best efforts to effect such transfers.

  • Other Regulatory Approvals Each party hereto shall cooperate and use its reasonable best efforts to promptly prepare and file all necessary documentation to effect all necessary applications, notices, petitions, filings and other documents, and use all reasonable efforts to obtain (and will cooperate with each other in obtaining) any consent, acquiescence, authorization, order or approval of, or any exemption or nonopposition by, any Governmental Entity required to be obtained or made by Parent or the Company or any of their respective Subsidiaries in connection with the Offer and the Merger or the taking of any other action contemplated by this Agreement.

  • Regulatory Applications (a) Sky and SBI and their respective Subsidiaries shall cooperate and use their respective reasonable best efforts to prepare, within 45 days of the execution of this Agreement, all documentation and requests for regulatory approval, to timely effect all filings and to obtain all permits, consents, approvals and authorizations of all third parties and Governmental Authorities and Regulatory Authorities necessary to consummate the transactions contemplated by this Agreement. Each of Sky and SBI shall have the right to review in advance, and to the extent practicable each will consult with the other, in each case subject to applicable laws relating to the exchange of information, with respect to, and shall be provided in advance so as to reasonably exercise its right to review in advance, all material written information submitted to any third party or any Governmental Authority or Regulatory Authority in connection with the transactions contemplated by this Agreement. In exercising the foregoing right, each of the parties hereto agrees to act reasonably and as promptly as practicable. Each party hereto agrees that it will consult with the other party hereto with respect to the obtaining of all material permits, consents, approvals and authorizations of all third parties and Governmental Authorities or Regulatory Authorities necessary or advisable to consummate the transactions contemplated by this Agreement and each party will keep the other party apprised of the status of material matters relating to completion of the transactions contemplated hereby.

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