Government Approvals and Clinical Trials Sample Clauses

Government Approvals and Clinical Trials. 6.2.1. GRELAN agrees to (a) conduct or cause to be conducted all clinical trials and other studies of any nature of the Venture Products necessary or desirable for efficiently obtaining Government Regulatory Approvals in the Territory and (b) prepare and submit all documents necessary or desirable for obtaining Government Regulatory Approvals in the Territory. GRELAN shall be solely responsible for paying the costs of such clinical development and regulatory approvals described in the previous sentence and GRELAN shall reimburse KI PHARMA for all costs of any such clinical development and regulatory approvals paid by KI PHARMA. If permitted by laws in the Territory, the Government Regulatory Approvals for Venture Products shall be obtained in the name of KI PHARMA, and GRELAN shall provide such additional assistance as may be necessary to assure that such Approvals are obtained in the name of KI PHARMA. Such assistance shall include, without limitation, acting as an agent of KI PHARMA where necessary to facilitate the regulatory process. If the Government Regulatory Approvals are not permitted to be obtained by KI PHARMA in the name of KI PHARMA, then, with the consent of GRELAN and BIONUMERIK (which consent will not be unreasonably withheld) such approvals will be obtained in the name of GRELAN. To the extent permitted by laws in the Territory,
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Government Approvals and Clinical Trials. 4.2.1. ASTA Medica agrees at its sole expense to (a) conduct or cause to be conducted all clinical trials and other studies of any nature of the Product(s) necessary or desirable for obtaining Government Regulatory Approvals and (b) prepare and submit all documents necessary or desirable for obtaining Government Regulatory Approvals. The Alliance Steering Committee will mutually determine the priority of each country in the Territory for development, registration and marketing of the Product(s) within a reasonable period of time following the date of this Agreement. The Alliance Steering Committee will update the priority list on a semi-annual basis. In connection therewith, ASTA Medica shall, at its own expense and in accordance with the priorities determined by the Alliance Steering Committee, apply for all health registrations and Government Regulatory Approvals required to execute and to perform this Agreement. To the extent permitted by laws in the Territory and if requested by ASTA Medica, BioNumerik agrees to assist and support the process of obtaining the Government Regulatory Approvals by providing input and assistance from Xx. Xxxxxxxxx X. Hausheer regarding the design and conduct of non-clinical studies, clinical trials, preparation of regulatory submissions and review, analysis and presentation of laboratory data. During the term of this Agreement, ASTA Medica shall be the marketing, development and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. distribution authorization holder of the Product(s) in the Territory unless otherwise agreed to by the Alliance Steering Committee. ASTA Medica shall keep BioNumerik regularly and fully informed of the status of the Government Regulatory Approvals process on a current basis and furnish BioNumerik upon BioNumerik's reasonable request with copies of all of the documents, data and other information supplied to or received from applicable government authorities in connection with the applications for the Government Regulatory Approvals. Upon receipt of the Government Regulatory Approvals, ASTA Medica shall promptly furnish BioNumerik copies or other satisfactory evidence thereof. In addition, ASTA Medica may conduct research and development (including studies and clinical trials) of the Product(s) outside the Territory for the purpose of supporting the development and commerci...
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Related to Government Approvals and Clinical Trials

  • 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;

  • 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.

  • 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; 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.

  • 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.

  • 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”).

  • Regulatory Approvals and Related Matters (a) Each party shall use reasonable best efforts to file, as soon as practicable after the date of this Agreement, all notices, reports and other documents required to be filed by such party with any Governmental Body with respect to the Merger and the other Contemplated Transactions, and to submit promptly any additional information requested by any such Governmental Body. Without limiting the generality of the foregoing, the Company and Parent shall, promptly (and in any event within 10 days) after the date of this Agreement, prepare and file the notifications required under any Legal Requirement that is designed to prohibit, restrict or regulate actions having the purpose or effect of monopolization or restraint of trade (collectively, “Antitrust Laws”) in connection with the Merger. The Company and Parent each shall promptly (i) supply the other party with any information which may be required in order to effectuate notices, reports, documents or other filings with any Governmental Body required to be made pursuant to any Antitrust Laws (including the HSR Act) (the “Antitrust Filings”); and (ii) supply any additional information which reasonably may be required by any Governmental Body in connection with Antitrust Filings or which the parties may reasonably deem appropriate. Each of the Company and Parent will notify the other party promptly upon the receipt of (A) any comments from any Governmental Bodies in connection with any Antitrust Filings made pursuant hereto; and (B) any request by any Governmental Bodies for amendments or supplements to any Antitrust Filings made pursuant to, or information provided to comply in all material respects with, any Legal Requirements, including the requirements of the HSR Act. Whenever any event occurs that is required to be set forth in an amendment or supplement to any Antitrust Filings, the Company or Parent, as the case may be, will promptly inform the other party of such occurrence and cooperate in filing with the applicable Governmental Body such amendment or supplement. Each of the Company and Parent shall give the other party prompt notice of the commencement or known threat of commencement of any Legal Proceeding by or before any Governmental Body with respect to the Merger or any of the other Contemplated Transactions, keep the other party reasonably informed as to the status of any such Legal Proceeding or threat, and in connection with any such Legal Proceeding, each of the Company or Parent will permit authorized representatives of the other party to be present at each meeting or conference relating to any such Legal Proceeding and to have access to and be consulted in connection with any document, opinion or proposal made or submitted to any Governmental Body in connection with any such Proceeding.

  • Regulatory Approval Any waiting period applicable to the Transactions under the HSR Act shall have been terminated or shall have expired.

  • Approvals of Regulatory Authorities Niagara Bancorp shall have received all required approvals of Regulatory Authorities of the Merger (without the imposition of any conditions that are in Niagara Bancorp's reasonable judgment unduly burdensome); and all notice and waiting periods required thereunder shall have expired or been terminated;

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