Regulatory Correspondence Requiring a Response Sample Clauses

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.
Sample 1Sample 2
AutoNDA by SimpleDocs
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.
Sample 1
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.
Sample 1
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.
Sample 1

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.

  • Information for Regulatory Compliance Each of the Company and the Depositary shall provide to the other, as promptly as practicable, information from its records or otherwise available to it that is reasonably requested by the other to permit the other to comply with applicable law or requirements of governmental or regulatory authorities.

  • 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.

  • 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.

  • 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)

  • Drug-Free Workplace Certification As required by Executive Order No. 90-5 dated April 12, 1990, issued by the Governor of Indiana, the Company hereby covenants and agrees to make a good faith effort to provide and maintain a drug-free workplace at the Project Location. The Company will give written notice to the IEDC within ten (10) days after receiving actual notice that the Company, or an employee of the Company in the State of Indiana, has been convicted of a criminal drug violation occurring in the workplace. False certification or violation of this certification may result in sanctions including, but not limited to, suspension of payments under the Agreement, termination of the Agreement and/or debarment of contracting opportunities with the State for up to three (3) years. In addition to the provisions of the above paragraph, if the total amount set forth in the Agreement is in excess of $25,000.00, the Company agrees that it will provide a drug-free workplace by: A. Publishing and providing to all of its employees a statement notifying them that the unlawful manufacture, distribution, dispensing, possession or use of a controlled substance is prohibited in the Company’s workplace, and specifying the actions that will be taken against employees for violations of such prohibition;

  • Prior Notification Unless specifically prohibited by applicable law or court order, each of the Banks and the Agent shall, prior to disclosure thereof, notify the Borrower of any request for disclosure of any such non-public information by any governmental agency or representative thereof (other than any such request in connection with an examination of the financial condition of such Bank by such governmental agency) or pursuant to legal process.

  • Certain Notifications (a) From the date hereof until the Closing, except as Previously Disclosed, AIG shall promptly notify the FRBNY, the UST and the Trust of (i) any fact, event or circumstance to the knowledge of AIG which would reasonably be expected to cause any representation or warranty of AIG contained in this Agreement to be untrue or inaccurate in any material respect or to cause any covenant or agreement of AIG or any SPV contained in this Agreement not to be complied with or satisfied in any material respect, (ii) any fact, circumstance, event, change, occurrence, condition or development of which AIG is aware and which, individually or in the aggregate, has had or would reasonably be expected to have an AIG Material Adverse Effect or (iii) any notice or other communication from any Person alleging that the consent of such Person is or may be required in connection with the transactions contemplated by the Transaction Documents; provided, however, that delivery of any notice pursuant to this Section 9.05(a) shall not limit or affect any rights of or remedies available to the FRBNY, the UST, the Trust or any of the Trustees; provided, further, that a failure to comply with clause (i) or (ii) of this Section 9.05(a) shall not constitute a breach of this Agreement or the failure of any condition set forth in Section 10.02(a) to be satisfied unless the underlying AIG Material Adverse Effect or material breach would independently result in the failure of a condition set forth in Section 10.02(a) to be satisfied. (b) From and after the Closing Date, AIG shall promptly notify the FRBNY and the UST of any fact, event or circumstance to the knowledge of AIG which would reasonably be expected to cause any covenant or agreement of AIG or any SPV contained in this Agreement that contemplates performance after the Closing Date not to be complied with or satisfied in any material respect; provided, however, that delivery of any notice pursuant to this Section 9.05(b) shall not limit or affect any rights of or remedies available to the FRBNY or the UST.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!