FDA and Other Regulatory Matters Sample Clauses

FDA and Other Regulatory Matters. (a) Each Loan Party and its Subsidiaries has, and it and its Products are in conformance with, all Registrations applicable to its respective business except where the failure to have such Registrations or be in conformance would not reasonably be expected to have, either individually or in the aggregate, a Material Adverse Effect. No Loan Party nor any of its Subsidiaries has received written notice that the FDA or any other Governmental Authority intends to suspend or revoke such Registrations or changing the marketing classification affecting the Products of the Loan Parties or any of their respective Subsidiaries. To the knowledge of each Loan Party and its Subsidiaries, there is no material false or misleading information or material omission in any product application or other submission to the FDA or other Governmental Authority administering Public Health Laws. To the knowledge of each Loan Party and its Subsidiaries, no event has occurred or condition or state of facts exists which would cause revocation or termination of any such Registration. To the knowledge of each Loan Party and its Subsidiaries, any third party that is a manufacturer or contractor for the Loan Parties or any of their respective Subsidiaries is in compliance in all material respects with all Registrations required by the FDA or comparable Governmental Authority and all Public Health Laws insofar as they reasonably pertain to the Products of the Loan Parties and their respective Subsidiaries.
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FDA and Other Regulatory Matters. (a) Except as set forth in Schedule 3.11(a), if applicable, none of the BioD Companies has received any notice or other communication from any Government Entity (i) contesting the uses of or the labeling and promotion of any of the products sold by the BioD Companies (“BioD Company Products”) or (ii) otherwise alleging any violation of any Law by any of the BioD Companies with respect to any BioD Company Products, excluding all observations communicated in FDA Form 483s resolved prior to 2013.
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FDA and Other Regulatory Matters. Except as set forth in -------------------------------- Section 3.13(b) of the Disclosure Schedule, (i) there are no lawsuits, -------------- arbitrations, legal or administrative or regulatory proceedings or charges by the U.S. Food and Drug Administration ("FDA"), the U.S. Drug Enforcement Agency --- (the "DEA"), the U.S. Department of Justice (the "DOJ") or any other --- --- Governmental Entity relating to the business of MRL pending or, to the Knowledge of MRL, threatened against or relating to MRL, (ii) to the Knowledge of MRL, there are no complaints or investigations by the FDA, DEA, DOJ or any other Governmental Entity pending or, to the Knowledge of MRL, threatened against or relating to MRL, (iii) to the Knowledge of MRL, the work undertaken by MRL, including work performed in connection with clinical trials, has been and is being conducted in substantial compliance with all applicable laws, regulations and professional and industry (including clinical and laboratory practice) standards, (iv) neither MRL nor, to the Knowledge of MRL, any of its officers, employees or agents, has made an untrue statement of a material fact or material fraudulent statement to the FDA, the DEA or any other Governmental Entity, failed to disclose a material fact required to be disclosed to any of them or committed an act, made a statement or failed to make a statement that could reasonably be expected to provide a basis for any of them to invoke the policy respecting "Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities" set forth in 56 Fed. Reg. 46191 (September 10, 1991) or equivalent regulations, (v) there are no unresolved reports, warning letters or other documents received from or issued by the FDA, the DEA or other Governmental Entity that indicate or suggest a material lack of compliance with applicable regulatory requirements by MRL or persons providing services for the benefit of any of them, (vi) no person has filed a claim against MRL for loss or potential loss based on the work undertaken by any of them and (vii) neither MRL nor, to the Knowledge of MRL, any of its officers, employees, agents or affiliates has been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C.(S)335(a) or authorized by 21 U.S.C.(S)335(a). MRL has made available to PPD prior to the execution and delivery of this Agreement copies of all material written communications delivered during the last five (5) years to or from t...
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FDA and Other Regulatory Matters. (i) The Seller has all authorizations, approvals, licenses and orders of and from all governmental and regulatory offices, agencies, officers and bodies necessary to carry on the Business as it is currently being conducted, to own or hold under lease the properties and assets relating to the Business it owns or holds under lease and to perform all of its obligations under all agreements relating to the Business to which it is a party (collectively, the "Licenses"), and the Seller has been and is in compliance with all applicable laws, regulations and administrative orders of any country, state or municipality or of any subdivision thereof to which the Business and its employment of labor or its use or occupancy of properties or any part thereof are subject. Schedule 4.7(E)(i) sets forth a true and complete list of all material Licenses.
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FDA and Other Regulatory Matters. (a) Except as set forth on Schedule 4.19(a) hereto, there are no unfulfilled outstanding agreements with or commitments to the FDA or any other regulatory body of any kind or character with respect to any Product; there are no adverse regulatory actions by the FDA or any other regulatory body (domestic or foreign) pending with respect to any Product; and Seller does not have any knowledge or information with respect to the initiation, pendency or threat by the FDA or other such regulatory body of any adverse regulatory action affecting any of the Products. Any Products manufactured or sold in the United States (i) are not misbranded or adulterated and (ii) have been produced in accordance with Good Manufacturing Practices, in each case within the meaning of the Act and any applicable FDA, state and local regulations.
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Related to FDA and Other Regulatory Matters

  • Regulatory and Other Approvals Purchaser will (a) take all reasonable steps necessary or desirable, and proceed diligently and in good faith and use all reasonable efforts, at the earliest commercially practicable dates, to obtain all consents, approvals or actions of, to make all filings with and to give all notices to Governmental or Regulatory Authorities or any other Person required of Purchaser to consummate the transactions contemplated hereby and by the Operative Agreements, including those described in Section 3.03 of the Disclosure Schedule and Purchaser Required Regulatory Approvals or for Purchaser to own, operate or maintain, on and after the Closing, the Assets substantially as such assets are currently owned, operated and maintained by Seller, (b) provide such other information and communications to such Governmental or Regulatory Authorities or other Persons as such Governmental or Regulatory Authorities or other Persons may reasonably request in connection therewith and (c) provide reasonable cooperation to Seller in obtaining Seller Required Regulatory Approvals and all other consents, approvals or actions of, making all filings with and giving all notices to Governmental or Regulatory Authorities or other Persons required of Seller to consummate the transactions contemplated hereby and by the Operative Agreements. Prior to making any filings with a Governmental or Regulatory Authority pursuant to this Section 5.01, Purchaser agrees to provide copies of such filings to Seller. Nothing in this Agreement shall require Purchaser to institute litigation or to pay or agree to pay any sum of money or make financial accommodations (other than the payment or incurrence of customary expenses and filing or other fees) in order to obtain any necessary consent, approval or authorization including, without limitation, the Purchaser Required Regulatory Approvals. Purchaser will provide prompt notification to Seller when any such consent, approval, action, filing or notice referred to in clause (a) above is obtained, taken, made or given, as applicable, and will advise Seller of any communications (and, unless precluded by Law, provide copies of any such communications that are in writing) with any Governmental or Regulatory Authority or other Person regarding any of the transactions contemplated by this Agreement or any of the Operative Agreements.

  • Regulatory and Other Authorizations Each party hereto shall use its commercially reasonable efforts to obtain all authorizations, consents, orders and approvals of any Governmental Authority that may be or become necessary for its execution and delivery of, and the performance of its obligations pursuant to, this Agreement and will cooperate fully with the other party in promptly seeking to obtain all such authorizations, consents, orders and approvals.

  • Regulatory and Other Matters (a) The parties shall, and shall cause their respective Subsidiaries to, cooperate with each other and use their respective commercially reasonable efforts to promptly prepare and file all necessary documentation, to effect all applications, notices, petitions and filings with any Third Party or Governmental Entity and to take any further actions reasonably requested by the other party to obtain as promptly as practicable the Required Approvals and other consents required to be obtained in connection with the Merger and the other transactions contemplated by this Agreement. MDLY and SIC shall have the right to review in advance, and, to the extent practicable, each will consult with the other on, in each case subject to Applicable Laws relating to the confidentiality of information, all information relating to MDLY or SIC, as the case may be, and any of their respective Subsidiaries, that appear in any filing made with, or written materials submitted to, any Third Party or any Governmental Entity in connection with obtaining the Required Approvals. In exercising the foregoing right, each of the parties shall act reasonably and as promptly as reasonably practicable. The parties shall consult with each other with respect to the obtaining of the Required Approvals and each party will keep the other apprised of the status of matters relating to completion of the transactions contemplated by this Agreement.

  • Pollution and Other Regulations Each of the Credit Parties:

  • Regulatory and Other Authorizations; Consents (a) Each party hereto shall use all commercially reasonable efforts to obtain all authorizations, consents, orders and approvals of, and to give all notices to and make all filings with, all Governmental Entities (including but not limited to those pertaining to the Governmental Approvals) and other third parties that may be or become necessary for its execution and delivery of, and the performance of its obligations pursuant to this Agreement and will cooperate fully with the other party in promptly seeking to obtain all such authorizations, consents, orders and approvals, giving such notices, and making such filings. To the extent required by the HSR Act, each of the parties hereto shall (i) file or cause to be filed, as promptly as practicable but in no event later than 15 days after (x) the execution and delivery of this Agreement or (y) such later date as a change of circumstances causes such a filing to be required, with the Federal Trade Commission and the United States Department of Justice, all reports and other documents required to be filed by such party under the HSR Act concerning the transactions contemplated hereby and (ii) promptly comply with or cause to be complied with any requests by the Federal Trade Commission or the United States Department of Justice for additional information concerning such transactions, in each case so that the waiting period applicable to this Agreement and the transactions contemplated hereby under the HSR Act shall expire as soon as practicable after the execution and delivery of this Agreement. Each party hereto agrees to request, and to cooperate with the other party or parties in requesting, early termination of any applicable waiting period under the HSR Act. Savia shall pay the filing fees payable in connection with the filings by the parties required by the HSR Act.

  • Government and Other Regulations This Option is subject to all laws, regulations and orders of any governmental authority which may be applicable thereto and, notwithstanding any of the provisions hereof, the Holder agrees that the Holder will not exercise the Option granted hereby nor will the Company be obligated to issue or sell any shares of stock hereunder if the exercise thereof or the issuance or sale of such shares, as the case may be, would constitute a violation by the Holder or the Company of any such law, regulation or order or any provision thereof. The Company shall not be obligated to take any affirmative action in order to cause the exercise of this Option or the issuance or sale of shares pursuant hereto to comply with any such law, regulation, order or provision.

  • Regulatory and Other Notices Promptly after Borrower’s receipt thereof, copies of any notices or other communications received from any Governmental Authority with respect to any matter or proceeding the effect of which could reasonably be expected to have a Material Adverse Effect.

  • Government and Other Approvals No approval, consent, exemption or other action by, or notice to or filing with, any governmental authority is necessary in connection with the execution, delivery or performance of the Loan Documents required hereunder.

  • Compliance with Laws and Other Requirements (A) Tenant shall cause the Premises to comply in all material respects with all laws, ordinances, regulations and directives of any governmental authority having jurisdiction including, without limitation, any certificate of occupancy and any law, ordinance, regulation, covenant, condition or restriction affecting the Building or the Premises which in the future may become applicable to the Premises (collectively "Applicable Laws").

  • Organizational and Other Matters Section 2.01 The Company was formed as a limited liability company under the provisions of the Act by the filing of the Certificate with the Secretary of State of the State of Delaware on 22 June 2007. The rights and liabilities of the Member shall be as provided in the Act, except as otherwise expressly provided herein. F:\USERS\jengllsh\Office\ENSCO Drilling Mexico LLC\Amended LLC Agreement

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