Regulatory/Government Approvals Sample Clauses

Regulatory/Government Approvals. The Company shall provide to the Distributor all documentation and assistance which is reasonably necessary for the Distributor to obtain the regulatory or other governmental approvals and clearances necessary for marketing and distribution of the Products in the Territory. The Distributor agrees to use its reasonable efforts to obtain such regulatory or other governmental approvals and clearances in a timely manner in the Territory. It is contemplated that the Distributor files application(s) for such approvals or clearances after the Company has secured the GMP, or is in the process of securing the GMP, under the United States FDA regulations and has provided the Distributor with all information prepared for obtaining such GMP status. The Company further agrees to provide the Distributor with all current information of the kind which is generally made available by manufacturers of medical devices to their sales and service personnel concerning hardware and software modifications or upgrades to the Products. The Distributor also agrees to report to the Ministry of Health and Welfare of Japan accumulated clinical results, including occurrence of side effects, obtained by the customer sites through use of the PRSs. In case of any problem which has to be dealt with as a manufacturer of the PRS, the Company shall provide necessary technical assistance including remodeling of the PRSs without charge to the Distributor and the customers. The Company shall use its reasonable efforts to cause Radionics, Inc. ("Radionics") to obtain any regulatory or other governmental approvals and clearances for marketing and distribution of its stereotactic frame so as to help the sale and marketing of the PRS by the Distributor in the Territory. The Company agrees to negotiate with Radionics to sell the frame to customers of the PRS in the Territory at a discount price.
Sample 1
AutoNDA by SimpleDocs

Related to Regulatory/Government Approvals

  • Government Approvals All authorizations, consents, orders or approvals of, or declarations or filings with, or expiration of waiting periods imposed by, any governmental authority necessary for the consummation of the transactions contemplated by this Agreement shall have been filed, occurred or been obtained.

  • No Government Approval No federal or state agency has passed upon the Securities, recommended or endorsed the Offering, or made any finding or determination as to the fairness of this transaction;

  • Government Approval Boeing and Customer will assist each other in obtaining any governmental consents or approvals required to effect certification and sale of aircraft under the applicable purchase agreement.

  • Regulatory Consents The waiting period applicable to the consummation of the Merger under the HSR Act shall have expired or been earlier terminated.

  • Governmental and Regulatory Approvals Other than the filing of the Articles of Merger provided for under Section 1.3, all consents, approvals and actions of, filings with and notices to any Governmental Entity required by the Company, Parent or any of their subsidiaries under applicable law or regulation to consummate the Merger and the transactions contemplated by this Agreement, the failure of which to be obtained or made would result in a material adverse effect on Parent’s ability to conduct the business of the Company in substantially the same manner as presently conducted, shall have been obtained or made (all such approvals and the expiration of all such waiting periods, the “Requisite Regulatory Approvals”).

  • 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 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.

  • Governmental and Regulatory Consents All material filings required to be made prior to the Closing with, and all material consents, approvals, permits and authorizations required to be obtained prior to the Closing from, Governmental Entities, in connection with the execution and delivery of this Agreement and the consummation of the transactions contemplated hereby by Holding Co and Public Company will have been made or obtained (as the case may be).

  • Government Approvals and Required Consents The Company, the Stockholders, NewCo and APP shall have obtained all licenses, permits and all necessary government and other third-party approvals and consents required under any law, statements, rule, regulation or ordinance to consummate the transactions contemplated by this Agreement.

  • Regulatory Filings and Approvals Copies of all necessary governmental and third party approvals, registrations, and filings in respect of the transactions contemplated by this Agreement;

Time is Money Join Law Insider Premium to draft better contracts faster.