Acquisition and Maintenance of Authorization Sample Clauses

Acquisition and Maintenance of Authorization. CONFORMA shall have the sole responsibility for preparing and filing the INDs and the NDA for the Product with the Regulatory Authority in the countries where CONFORMA has an intention to market the Finished Product. CONFORMA shall immediately notify SUMITOMO of the submission of any IND and NDA for the Product and of the grant of any Authorization. CONFORMA shall be responsible for applying for and obtaining any extensions of the Data Protection period in countries where CONFORMA markets the Product. CONFORMA shall use Commercially Reasonable Efforts to make regulatory filings in the countries where CONFORMA has an intention to market the Finished Product, contingent on SUMITOMO fulfilling its obligations under Sections 4.1(i) and 4.1(iii) of this Agreement and supply obligations under Section 6 or the Supply Agreement. CONFORMA shall be solely responsible for any actions, including but not limited to clinical trials after obtaining the Authorization, at its expense to maintain each Authorization in the countries where CONFORMA markets the Product. CONFORMA shall be responsible for all interactions with Regulatory Authorities in the Territory. Authorization shall be held by CONFORMA in CONFORMA’s name in the Territory. CONFORMA will have the sole responsibility for applying for, obtaining and maintaining Authorization in the Territory. All expenses necessary for applying for, obtaining and maintaining Authorization in the Territory shall be borne by CONFORMA. At CONFORMA’s request, SUMITOMO shall cooperate in the preparation and maintenance of all regulatory filings for the Finished Product filed by CONFORMA, including, without limitation, preparing sections of regulatory filings that are applicable to the manufacturing activities of SUMITOMO or to preclinical, clinical and commercial data generated by SUMITOMO.
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Related to Acquisition and Maintenance of Authorization

  • Evidence of Authority The Custodian shall be protected in acting upon any instructions, notice, request, consent, certificate or other instrument or paper believed by it to be genuine and to have been properly executed by or on behalf of the Fund. The Custodian may receive and accept a certified copy of a vote of the Board of Directors of the Fund as conclusive evidence (a) of the authority of any person to act in accordance with such vote or (b) of any determination or of any action by the Board of Directors pursuant to the Articles of Incorporation as described in such vote, and such vote may be considered as in full force and effect until receipt by the Custodian of written notice to the contrary.

  • Reservation of Authority Nothing in this subpart shall limit the authority of the Secretary to take action to enforce conditions or violations of law, including actions necessary to prevent evasions of this subpart.

  • Warranty of Authority Each person signing this Amendment warrants that he or she is duly authorized to do so and to bind the respective party.

  • Letter of Authorization Each Party is responsible for obtaining a Letter of Authorization (LOA) from each End User initiating transfer of service from one Party to the other Party in accordance with applicable law. The Party obtaining the LOA from the End User will furnish it to the other Party upon request. The Party obtaining the LOA is required to maintain the original document, for a minimum of twenty-four (24) months from the date of signature. If there is a conflict between an End User and Carrier regarding the disconnection or provision of services, Frontier will honor the latest dated Letter of Authorization. If the End User’s service has not been disconnected and services have not yet been established, Carrier will be responsible to pay the applicable service order charge for any order it has placed. If the End User’s service has been disconnected and the End User’s service is to be restored with Frontier, Carrier will be responsible to pay the applicable nonrecurring charges as set forth in Frontier applicable tariff to restore the End User’s prior service with Frontier.

  • Proof of Authorization 5.3.1 Each Party shall be responsible for obtaining and maintaining Proof of Authorization (POA) as required by applicable federal and state law, as amended from time to time.

  • Representation of Authority Each individual executing this Agreement on behalf of a party hereto hereby represents and warrants that he or she is, on the date he or she signs this Agreement, duly authorized by all necessary and appropriate action to execute this Agreement on behalf of such party and does so with full legal authority.

  • Scope of Authority Committee meetings will be used for communications between the parties, to share information and to address concerns. The committee will have no authority to conduct any negotiations or modify any provision of this Agreement. The committee’s activities and discussions will not be subject to the grievance procedure in Article 30.

  • Termination of Authority Immediately upon the Executive terminating or being terminated from his employment with the Company for any reason, notwithstanding anything else appearing in this Agreement or otherwise, the Executive will stop serving the functions of his terminated or expired position(s) and shall be without any of the authority or responsibility for such position(s).

  • Limitation of Authority No person is authorized to make any representations concerning the Funds or the Shares except those contained in the Prospectus of each Fund and in such printed information as the Distributor may subsequently prepare. No person is authorized to distribute any sales material relating to any Fund without the prior written approval of the Distributor.

  • Confirmation of Authority; Execution of Releases Without in any manner limiting Agent’s authority to act without any specific or further authorization or consent by Lenders or Documentation Agent (as set forth in Section 11.1(h)(i) and (ii)), each Lender agrees to confirm in writing, upon request by Agent, the authority to release any property covered by this Agreement or the Loan Documents conferred upon Agent under Section 11.1(h)(ii). So long as no Event of Default exists, upon receipt by Agent of confirmation from the requisite percentage of the Lenders of its authority to release any particular item or types of Property covered by this Agreement or the other Loan Documents, and upon at least five (5) Business Days’ prior written request by Borrower Funds Administrator, Agent shall (and hereby is irrevocably authorized by Lenders to) execute such documents as may be necessary to evidence the release of the Liens granted to Agent, for the benefit of the Lender Parties, herein or pursuant hereto upon such Collateral; provided, however, that (A) Agent shall not be required to execute any such document on terms which, in Agent’s opinion, would expose Agent to liability or create any obligation or entail any consequence other than the release of such Liens without recourse or warranty (other than that such Collateral is free and clear, on the date of such delivery, of any and all Liens arising from such Person’s own acts), and (B) such release shall not in any manner discharge, affect or impair the Obligations or any Liens upon (or obligations of the Credit Parties or any Subsidiary of any Credit Party in respect of all interests retained by the Credit Parties or any Subsidiary of any Credit Party, including, without limitation, the proceeds of any sale, all of which shall continue to constitute part of the Property covered by this Agreement or the other Loan Documents).

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