Regulatory Correspondence Requiring a Response Clause Samples

The "Regulatory Correspondence Requiring a Response" clause establishes the obligation for a party to promptly notify and share with the other party any communications from regulatory authorities that require a formal response. In practice, this means if a company receives a letter, inquiry, or notice from a regulator that demands action or information, it must inform its contractual partner and may need to coordinate on the response. This clause ensures transparency and cooperation in regulatory matters, helping both parties manage compliance risks and respond appropriately to regulatory scrutiny.
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Regulatory Correspondence Requiring a Response. In the event that any Party receives any regulatory letter or comments from any Regulatory Authority directed to the manufacture of Bulk or Finished Product requiring a response or action by such Party, the other Party (as applicable) promptly will provide the Party who received such notice with any data or information required by such Party in preparing any response relating to the manufacture of Bulk or Finished Product, and will cooperate fully with such Party in preparing such response. The Party responding to such notice shall provide the other Party with a copy of each such response for such other Party’s review and comment prior to submission of the response. The Party submitting the response shall give all due consideration to any comments of the other Party on each such proposed response.
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Regulatory Correspondence Requiring a Response. In the event that Athenex (or any Affiliate or contractor thereof) or Almirall (or any Affiliate thereof or Sublicensee of it or its Affiliates) receives any material regulatory letter or comments from any Regulatory Authority in the Territory relating to the Development, manufacture, or Commercialization of Licensed Product in the Field in the Territory, such Party will promptly provide the other Party with any data or information required by the other Party in preparing any response in the Territory relating to such Development, manufacture, or Commercialization of Licensed Product in the Field in the Territory, and will cooperate fully with the applicable Party in preparing such response. To the extent reasonably practicable (subject to the time a response is mandated), the responding Party shall provide the other Party with a copy of each such proposed response for the other Party’s review and comment at least ten (10) Business Days prior to the proposed submission of the response. The responding Party shall give good faith consideration to any of the other Party’s comments to each such proposed response and shall incorporate such comments to the extent the responding Party deems necessary or appropriate. Athenex shall have the final decision with respect to any responses or actions required by any such letter or comments with respect to the Athenex Studies, the initial NDA for the Current Product in the Field in the U.S., except if any such Athenex’s decision may have any material and adverse impact on (z) any Almirall’s decision making right recognized in other parts of this Agreement; (y) the timelines agreed in the Development Plan; (x) the Regulatory Approvals for the Current Product; (w) the Commercialization of the Current Product in the Field in the Territory, including changes to Product Labeling that are reasonably likely to have such an effect; (v) any cost to be assumed or paid by Almirall under this Agreement or the Supply Agreement; (u) any of Almirall’s future obligations as holder of the Regulatory Approvals; or (t) the Post-Approval Development Activities, for which matters (z) to (t) Almirall’s prior written consent is needed; Almirall shall have the final decision with respect to any other responses or actions required by such letter or comments with respect to Licensed Products in the Field in the Territory.
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Regulatory Correspondence Requiring a Response. In the event that BDSI or Endo receives any material regulatory letter or comments from any Regulatory Authority relating to the development or Manufacture of Product, BDSI will promptly provide Endo with any data or information required by Endo in preparing any response in the Territory relating to BDSI’s development or Manufacture of Product, and will cooperate fully with Endo in preparing such response. To the extent reasonably practicable (subject to the time a response is mandated), Endo shall provide BDSI with a copy of each such response for BDSI’s review and comment at least *** prior to Endo’s submission of the response. Endo shall give good faith consideration to any BDSI comments to each such proposed Endo response and shall incorporate such comments to the extent Endo deems necessary or appropriate. Endo shall have the final decision with respect to any responses or actions required by such letter or comments.
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Regulatory Correspondence Requiring a Response. In the event that Toyama receives any material regulatory letter or comments from any Governmental Authority relating to the Development, manufacture, or Commercialization of Licensed Product in or for the Territory or relating to the use or manufacture of Compound or Permitted Derivative pursuant to the exercise of Supply Rights in the Manufacturing Territory which requires any data or information in Cempra’ s possession and Control, Cempra will cooperate with Toyama upon a written request from Toyama by making reasonable efforts to provide such data and information within a reasonable period, including by providing access to relevant personnel of Cempra who may have relevant information and knowledge relating thereto and responding in a reasonably timely manner to questions and comments from Toyama in connection therewith.
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Related to Regulatory Correspondence Requiring a Response

  • CERTIFICATION REGARDING DRUG-FREE WORKPLACE REQUIREMENTS 1. The Contractor certifies that it will provide a drug-free workplace by: a. Publishing a statement notifying employees that the unlawful manufacture, distribution, dispensing, possession or use of a controlled substance is prohibited in the Contractor’s workplace and specifying the actions that will be taken against employees for violation of such prohibition;

  • Required Notifications Each Grantor shall promptly notify the Administrative Agent, in writing, of: (i) any Lien (other than Permitted Liens) on any of the Collateral which would adversely affect the ability of the Administrative Agent to exercise any of its remedies hereunder and (ii) the occurrence of any other event which could reasonably be expected to have a material impairment on the aggregate value of the Collateral or on the security interests created hereby.

  • Certification Regarding Lobbying Applicable to Grants Subgrants, Cooperative Agreements, and Contracts Exceeding $100,000 in Federal Funds Submission of this certification is a prerequisite for making or entering into this transaction and is imposed by section 1352, Title 31, U.S. Code. This certification is a material representation of fact upon which reliance was placed when this transaction was made or entered into. Any person who fails to file the required certification shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure. The undersigned certifies, to the best of his or her knowledge and belief, that: (1) No Federal appropriated funds have been paid or will be paid by or on behalf of the undersigned, to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of congress, or an employee of a Member of Congress in connection with the awarding of a Federal contract, the making of a Federal grant, the making of a Federal loan, the entering into a cooperative agreement, and the extension, continuation, renewal, amendment, or modification of a Federal contract, grant, loan, or cooperative agreement.

  • Certification Regarding Debarment Party certifies under pains and penalties of perjury that, as of the date that this Agreement is signed, neither Party nor Party’s principals (officers, directors, owners, or partners) are presently debarred, suspended, proposed for debarment, declared ineligible or excluded from participation in Federal programs, or programs supported in whole or in part by Federal funds.

  • REQUIRED PRICE PROPOSAL RESPONSE All pricing must be fixed cost, inclusive of all expenses and fees if this Statement of Work proposal is for a fixed price agreement. (Remove if Time and Materials agreement) For Time and Materials the pricing proposal must include estimated effort hours, hourly rate for proposed personnel, projected timeline, including timing expectations for the State functional and technical resources and be submitted as a separate document from the rest of the proposal. (Remove if not Time and Materials)