MAA Approval Sample Clauses

MAA Approval. 6.1.1 As between the Parties, subject to the terms and conditions of the this Agreement, including without limitation Section 6.1.2 and the Quality and Regulatory Agreement, and Applicable Laws, (a) Iridex shall be responsible to prepare and file all MAA and secure all MAA Approvals for Products from all Regulatory Agencies necessary to market Products in (A) the Territory, except for Japan, (B) the United States and (C) outside the Territory, and (b) Topcon shall be responsible to prepare and file all MAA and secure all MAA Approvals for Products from all Regulatory Agencies necessary to market Products in Japan; provided, that, with respect to all countries and regions in the Territory other than Japan and the United States, the responsibilities shall be allocated based on good faith discussion among the Parties and reflected in the Quality and Regulatory Agreement (Iridex, with respect to all countries and regions in the Territory other than Japan, and Topcon, with respect to Japan, shall be referred to as “MAA Responsible Party”). Iridex shall own all right, title and interest in and to any and all MAA and MAA Approvals for Products in the Territory other than Japan, and Topcon shall own all right, title and interest in and to any and all MAA and MAA Approvals for Products in Japan. For clarity, and notwithstanding anything to the contrary herein, Iridex shall own all right, title and interest in and to any and all MAA and MAA Approvals for Products outside the Territory. 6.1.2 Iridex shall be responsible to prepare certain documents necessary to submit an MAA (such materials, “MAA Documents”) in Japan and other countries and regions in the Territory, including Third Party supporting certifications and materials (including translations), at its sole cost to the extent provided in the Quality and Regulatory Agreement or otherwise agreed in writing by the Parties. For clarity, all other costs and expenses of preparing and filing all MAA and securing all MAA Approvals in Japan will be borne by Topcon (or its Affiliates or Subdistributors). 6.1.3 The Parties shall discuss in good faith and agree in the Quality and Regulatory Agreement on (i) the actual roles and responsibilities of each Party and (ii) the responsibility and procedures relating to quality control and assurance and safety control of Products necessary under Applicable Law in each country or region in accordance with Section 3.7.
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MAA Approval. [*] within thirty (30) days of the first MAA approval for Product in the European Union or any country thereof.
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MAA Approval. Representative agrees that Company shall own and retain all right, title and interest in and to any and all MAA Approvals in the Territory.
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MAA Approval. NBY will have the right and responsibility to file and register all XXXx and seek all MAA Approvals in the Territory, and will own all right, title and interest in and to any and all XXXx and MAA Approvals in the Territory. NBY will keep Pioneer reasonably informed with respect to such matters (including meeting with Pioneer at least twice a year in person or by teleconference to discuss such matters) and Pioneer agrees to execute such documents, render such assistance, and take such other action as NBY may reasonably request, at NBY’s expense, to apply for, register, perfect, confirm, and protect NBY’s rights in the MAA Approvals. After NBY’s receipt of MAA Approvals in the Territory, if there is any material change(s) to NBY’s marketing approvals in U.S., NBY will promptly inform Pioneer of such change(s) and NBY, in its reasonable judgment, may file any additional Marketing Approval Applications with SFDA. ***Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commission.
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MAA Approval. Pioneer will file and register all XXXx and/or required registrations and seek all MAA and all necessary registration and government and Regulatory Approvals in the Territory. NBY shall furnish Pioneer with such assistance and cooperation as may be reasonably necessary in connection with securing of such government or Regulatory Approval. Pioneer will keep NBY reasonably informed with respect to such matters (including meeting at least twice a year in person or by teleconference to discuss such matters). NBY will reimburse Pioneer with the actual registration cost, provided, however such amount shall not exceed $[***] and such reimbursement shall be in the form of a credit towards Pioneer’s future purchase of the Product. NBY will provide reasonable amount of Products, free of change, for the purpose of sample testing and MAA approval if required by local authorities and regulations. After Pioneer’s receipt of MAA Approvals in the Territory, if there is any material change(s) to NBY’s marketing approvals in U.S., NBY will promptly inform Pioneer of such change(s) and Pioneer, in its reasonable judgment, may file any additional Regulatory Approval Applications with Regulatory Authorities in the Territory.
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MAA Approval. (i) Promptly after the Fourth Amendment Effective Date, and in any event no later than July 31st, the Parties shall take all actions necessary to transfer ownership of the MAA Approval for Staccato loxapine (ADASUVE) from Alexza to Xxxxxx. Such transfer shall be free of charge for Xxxxxx except with regard to regulatory fees. Upon positive European Commission decision of the transfer of ownership of the MAA Approval, Xxxxxx shall at all times be responsible, at its cost, for conducting the development and regulatory activities associated with maintaining MAA Approval (including any additional clinical or non-clinical studies that may be requested by the EMA, unless conducting such studies would be inconsistent with Xxxxxx’x exercise of Commercially Reasonable Efforts, and making Regulatory Filings and paying fees for Regulatory Filings, and including all scientific services requested by the EMA), except as otherwise set forth in the Fourth Amendment or as agreed by the Parties in writing; provided [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. that Xxxxxx’x responsibility for annual fees for maintaining the MAA Approval (for clarity, including pharmacoviligance costs) will commence on September 1, 2015. With respect to any additional variations to the MAA Approval, Alexza will be responsible for all costs incurred through September 1, 2015 for modifications planned or ongoing as of the Fourth Amendment Effective Date or proposed thereafter by Alexza, and Xxxxxx will be responsible for all costs incurred after September 1, 2015 for modifications proposed by Xxxxxx or required by Regulatory Authorities in the Territory. Any regulatory approvals granted in the European Union will be owned by Xxxxxx, and Xxxxxx shall be designated as the “marketing authorization holder” pursuant to the applicable EMA regulations. Alexza shall use Commercially Reasonable Efforts to cooperate and provide assistance in the conduct of any clinical and regulatory post-approval programs requested by Xxxxxx in response to requests by or efforts to satisfy the requirements of the EMA. (ii) The Parties and its Affiliates hereby mutually grant to each other a royalty-free right to reference all Regulatory Filings (including the MAA Approval), and use all data and other Know-How contained or re...
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Related to MAA Approval

  • 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.

  • 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.

  • HSR Approval The applicable waiting period under the HSR Act shall have expired or been terminated.

  • Regulatory Approvals (a) Each Party shall, and shall cause its ultimate parent entity (as such term is defined in the HSR Act) to, use reasonable best efforts to file or otherwise submit, as soon as practicable after the date of this Agreement, all applications, notices, reports, filings and other documents reasonably required to be filed by such Party or its ultimate parent entity with or otherwise submitted by such Party or its ultimate parent entity to any Governmental Body with respect to the Contemplated Transactions, and shall file no later than ten (10) Business Days thereafter the Notification and Report Forms required by the HSR Act. Each Party shall (i) promptly supply the other with any information which may be required in order to effectuate such filings, (ii) submit promptly any additional information which may be reasonably requested by any such Governmental Body, and (iii) coordinate with the other Party in making any such filings or information submissions pursuant to and in connection with the foregoing that may be necessary, proper, or advisable in order to consummate and make effective the Contemplated Transactions. (b) Without limiting the generality of anything contained in this Section 5.4, in connection with its efforts to obtain all requisite approvals and authorizations, and the expiration or termination of all applicable waiting periods for the Contemplated Transactions under any Antitrust Law, each Party hereto shall use its reasonable best efforts to (i) cooperate with the other with respect to any investigation or other inquiry; (ii) promptly provide to the other a copy of all communications received by such Party from, or given by such Party to, any Governmental Body, in each case regarding the Contemplated Transactions; and (iii) to the extent not prohibited under applicable Antitrust Law, permit the other to review in advance any communication given by it to any Governmental Body concerning the Contemplated Transactions, consider in good faith the views of the other in connection with any proposed written communications by such Party to any Governmental Body concerning the Contemplated Transactions, and consult with each other in advance of any meeting or telephone or video conference with, any Governmental Body, and give the other or its outside counsel the opportunity to attend and participate in such meetings and conferences unless prohibited by the applicable Governmental Body; provided, that materials required to be provided pursuant to this Section 5.4(b) may be restricted to outside counsel and redacted to (A) remove references concerning the valuation of either Party, (B) comply with contractual arrangements, and (C) preserve attorney-client privilege. Neither Party shall commit to or agree with any Governmental Body to stay, toll or extend any applicable waiting period under applicable Antitrust Law, or pull and refile under the HSR Act, without the prior written consent of the other. Parent and the Company shall each pay one-half of the filing fee under the HSR Act relating to the HSR filing required for the Merger; provided, however, that each Party shall bear its own legal fees. (c) Except as required by this Agreement, prior to Closing, neither the Company nor Parent shall, and shall cause its Affiliates not to, acquire or agree to acquire by merging or consolidating with, or by purchasing a substantial portion of the assets of or equity in, or by any other manner, any Person or portion thereof, or otherwise acquire or agree to acquire any assets, if the entering into of an agreement relating to or the consummation of such acquisition, merger or consolidation would reasonably be expected to (i) impose any delay in the obtaining of, or significantly increase the risk of not obtaining, any authorizations, consents, orders, declarations or approvals of any Governmental Body necessary to consummate the Contemplated Transactions or the expiration or termination of any applicable waiting period, or (ii) increase the risk of any Governmental Body entering an order prohibiting the consummation of the Contemplated Transactions.

  • Project Approval The County may issue a Job Order Authorization for the Work, to include the firm-fixed-price of the Job Order and the project duration. Contractor agrees that all clauses of this Contract are applicable to any Job Order issued hereunder. The County reserves the right to reject a Contractor’s Quote based on unjustifiable quantities and/or methods, performance periods, inadequate documentation, or other inconsistencies or deficiencies on the Contractor’s part in the sole opinion of the County. The County reserves the right to issue a unilateral Job Order authorization for the Work if a Quote price cannot be mutually agreed upon. This is based upon unjustifiable quantities in the sole opinion of the County. The County also reserves the right to not issue a Job Order Authorization if the County’s requirement is no longer valid or the project is not funded. In these instances, the Contractor has no right of claim to recover Quote expenses. The County may pursue continuing valid requirements by other means where Contract was not reached with the Contractor.

  • 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.

  • Listing Approval The Shares to be delivered on the Closing Date or any Additional Closing Date, as the case may be, shall have been approved for listing on the Exchange, subject to official notice of issuance. If (i) any of the conditions specified in this Section 5 shall not have been fulfilled when and as provided in this Agreement, or (ii) any of the opinions and certificates mentioned above or elsewhere in this Agreement shall not be reasonably satisfactory in form and substance to the Representative and its counsel, this Agreement and all obligations of the Underwriters hereunder may be cancelled on, or at any time prior to, the Closing Date or any Additional Closing Date, as the case may be, by the Representative. Notice of such cancellation shall be given to the Company in writing or by telephone or facsimile confirmed in writing.

  • FERC Approval Notwithstanding any other provision of this Appendix 2, no termination hereunder shall become effective until the Interconnected Entities and/or Transmission Provider have complied with all Applicable Laws and Regulations applicable to such termination, including the filing with the FERC of a notice of termination of the Interconnection Service Agreement, and acceptance of such notice for filing by the FERC.

  • FCC Approval Notwithstanding anything to the contrary contained in this Agreement or in the other Loan Documents, neither the Administrative Agent nor any Lender will take any action pursuant to this Agreement or any of the other Loan Documents, which would constitute or result in a change in control of the Borrower or any of its Subsidiaries requiring the prior approval of the FCC without first obtaining such prior approval of the FCC. After the occurrence of an Event of Default, the Borrower shall take or cause to be taken any action which the Administrative Agent may reasonably request in order to obtain from the FCC such approval as may be necessary to enable the Administrative Agent to exercise and enjoy the full rights and benefits granted to the Administrative Agent, for the benefit of the Lenders by this Agreement or any of the other Loan Documents, including, at the Borrower’s cost and expense, the use of the Borrower’s best efforts to assist in obtaining such approval for any action or transaction contemplated by this Agreement or any of the other Loan Documents for which such approval is required by Law.

  • Required Regulatory Approvals (a) The obligations of each Party under this Agreement are expressly contingent upon (i) each Party receiving all licenses, permits, permissions, certificates, approvals, authorizations, consents, franchises and releases from any local, state, or federal regulatory agency or other governmental agency or authority (which may include, without limitation and as applicable, the NYISO and the PSC) or any other third party that may be required for such Party in connection with the performance of such Party’s obligations under or in connection with this Agreement (the “Required Approvals”), (ii) each Required Approval being granted without the imposition of any modification or condition of the terms of this Agreement or the subject transactions, unless such modification(s) or condition(s) are agreed to by both Parties in their respective sole discretion, and (iii) all applicable appeal periods with respect to the Required Approvals having expired without any appeal having been made or, if such an appeal has been made, a full, final and non-appealable determination having been made regarding same by a court or other administrative body of competent jurisdiction, which determination disposes of or otherwise resolves such appeal (or appeals) to the satisfaction of both Parties in their respective sole discretion. (b) If any application or request is made in connection with seeking any Required Approval and is denied, or is granted in a form, or subject to conditions, that either Party rejects, in its sole discretion, as unacceptable, this Agreement shall terminate as of the date that a Party notifies the other Party of such denial or rejection, in which event the obligations of the Parties under this Agreement shall cease as of such date and this Agreement shall terminate, subject to NYSEG’s obligation to pay National Grid in accordance with the terms of this Agreement (including, without limitation, Section 10.3 above) for all Reimbursable Costs. All of National Grid’s actual costs in connection with seeking Required Approvals shall be included within the meaning of the term Reimbursable Costs and shall be paid for by NYSEG.

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