Investigational New Drug Applications Sample Clauses

Investigational New Drug Applications. 3.7.1 DCTD, NCI, as indicated in the Research Plan, will prepare and submit an IND(s) and all Clinical Investigators participating in DCTD-sponsored clinical trials must have completed registration documents on file (1572 forms) with CTEP.
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Investigational New Drug Applications. Except as disclosed in the General Disclosure Package and the Prospectus or as otherwise could not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect, (A) the Company has not failed to submit to the FDA an Investigational New Drug Application for a clinical trial it has conducted or sponsored or is conducting or sponsoring and (B) all such submissions were in material compliance with applicable laws and rules and regulations when submitted and no material deficiencies have been asserted by the FDA with respect to any such submissions.
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Investigational New Drug Applications. 3.7.1 If an IND is required, ICD, as indicated in the Research Plan, will be the IND Sponsor and will prepare and submit an IND. All Clinical Investigators participating in ICD-sponsored clinical trials must have completed registration documents on file (1572 forms) with ICD.
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Investigational New Drug Applications. 3.7.1 If an IND is required either ICD or Collaborator, DCTD, NCI, as indicated in the Research Plan, will prepare and submit an IND(s) and all Clinical Investigators participating in DCTD-sponsored clinical trials must have completed registration documents on file (1572 forms) with CTEP.
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Investigational New Drug Applications. 3.5.1 Approved Clinical Investigator will be the IND Sponsor for the clinical Study and will be responsible for all regulatory submissions to the FDA concerning the Study. Approved Investigator will cross-file on Collaborator’s IND and/or DMF, to the extent applicable, and will be responsible for all applicable regulatory information. All Approved Investigators participating in clinical trials must have current investigator registration documents (Form 1572, Financial Disclosure, NIH Biosketch) on file with the NCI for the purposes of identifying Approved Investigators qualified to participate on the NCI Formulary Study and for the purpose of trial conduct using NCI’s clinical trial infrastructure, but are also required to maintain their own Form FDA 1572 and Form FDA 3455 as Sponsor -investigator in accordance with 21CFR312 and 21CFR54, respectively.
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Investigational New Drug Applications. 3.7.2 If ICD elects to file its own IND, To support the NCI IND, Collaborator agrees to provide ICD NCI with background data and information necessary to support the IND, either directly or by way of cross reference as provided in the next sentence. Collaborator further agrees to provide a letter of cross-reference to all pertinent regulatory filings including any IND(s)_and/or DMF(s) sponsored by Collaborator. Collaborator’s employees will be reasonably available to respond to inquiries from the FDA regarding information and data contained in the Collaborator’s IND, DMF, other filings, or other information and data provided to ICD DCTD by the Collaborator pursuant to this Article 3.7. If ICD DCTD has provided information or data to assist Collaborator in its IND filing, ICD DCTD will provide a letter of cross reference to its IND and respond to inquiries related to information provided by ICD DCTD, as applicable.
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Investigational New Drug Applications. 3.7.1 DCTD, NCI, as provided in the Research Plan, has prepared and submitted an IND(s) covering the clinical research on the Investigational Agent conducted in accordance with the Protocol(s) under the CRADA LOI and to be conducted under this CRADA, and all Clinical Investigators participating in such DCTD-sponsored clinical trials must have completed registration documents on file (1572 forms) with CTEP. The DCTD hereby agrees to permit Collaborator and its Affiliates and Licensees to review, cross-reference and use the IND(s) in conducting Collaborator (and/or such Licensee’s) sponsored clinical trials and in Collaborator’s (and/or such Licensee’s) fulfilling all of the requirements necessary for obtaining FDA approval (and/or equivalent regulatory approvals in other countries or jurisdictions) to market Investigational Agent as an anti-cancer agent, which rights survive termination of this CRADA. Upon Collaborator’s request, DCTD will make all necessary filings with the FDA during the term of this CRADA to allow Collaborator (and its Licensees) such rights of cross-reference, and, if requested by Collaborator, shall provide Collaborator a letter acknowledging such rights of cross-reference, which Collaborator (and its Licensees) may use in regulatory filings with similar regulatory agencies in other countries. [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Investigational New Drug Applications. (i) Each Investigational New Drug application (“IND”) submitted by the Company to the FDA or equivalent application submitted by the Company to foreign regulatory bodies, and related documents and information, when submitted to the FDA or other regulatory body was true, complete and correct in all material respects as of the date of submission and has been maintained in compliance in all material respects with applicable statutes, rules and regulations administered or promulgated by the FDA or other regulatory body; (ii) the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company that are described in the Time of Sale Information or the Offering Memorandum were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards and applicable statutes, rules and regulations, including, but not limited to, the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 313; and the drug substances used in the clinical trials have been manufactured in all material respects under current Good Manufacturing Practices, including, but not limited to, FDA’s current good manufacturing practice regulations at 21 C.F.R. Parts 210-211; and (iii) the Company uses commercially reasonable efforts to review, from time to time, the progress and results of the studies, tests and preclinical and clinical trials and, based upon (1) the information provided to the Company by the third parties conducting such studies, tests and preclinical and clinical trials that are described in the Time of Sale Information and the Offering Memorandum and the Company’s review of such information, and (2) to the Company’s knowledge, such descriptions of the results of such studies, tests and preclinical and clinical trials are accurate and complete in all material respects. The Company has not received any written notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company. To the Company’s knowledge, no filing or submission to the FDA or any other regulatory body, that is intended to be the basis for any approval of the Company’s product candidates, contained or ...
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Investigational New Drug Applications. 3.7.1 Collaborator will prepare and submit a related IND. All Extramural Investigators must have completed registration documents on file (1572 forms) with the CCC.
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Related to Investigational New Drug Applications

  • FDA As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

  • Regulatory Cooperation In connection with any foreclosure, collection, sale or other enforcement of Liens granted to the Administrative Agent in the Collateral Documents, Parent will, and will cause its Restricted Subsidiaries to, reasonably cooperate in good faith with the Administrative Agent or its designee in obtaining all regulatory licenses, consents and other governmental approvals necessary or (in the reasonable opinion of the Administrative Agent or its designee) reasonably advisable to conduct all aviation operations with respect to the Collateral and will, at the reasonable request of the Administrative Agent and in good faith, continue to operate and manage the Collateral and maintain all applicable regulatory licenses with respect to the Collateral until such time as the Administrative Agent or its designee obtain such licenses, consents and approvals, and at such time Parent will, and will cause its Restricted Subsidiaries to, cooperate in good faith with the transition of the aviation operations with respect to the Collateral to any new aviation operator (including, without limitation, the Administrative Agent or its designee).

  • 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.

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