Notification to Other Parties of Regulatory Correspondence Sample Clauses

Notification to Other Parties of Regulatory Correspondence. Each Party shall promptly (and in any event, within two (2) Business Days of the date of receipt of notice) notify the other Party in writing of, and shall provide the other Party with copies of, any correspondence and other documentation received or prepared by such Party in connection with any of the following events:
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Notification to Other Parties of Regulatory Correspondence. Each Party shall immediately (and in any event, within at least three (3) business days of the date of receipt of notice) notify the other Party in writing of, and shall provide the other Party with copies of, any correspondence and other documentation received or prepared by such Party in connection with any of the following events: (1) receipt of a regulatory letter, Warning Letter, or similar item, from the FDA, EMEA or any other regulatory authority directed to the manufacture, packaging, and/or storage of Bulk Drug, or in connection with any general cGMP inspection applicable to the Lonza Facility or any other facility associated with any of Lonza's Services hereunder; (2) any recall, market withdrawal or correction of any Batch of Bulk Drug or resulting Product; and (3) any regulatory comments related to the manufacture of Bulk Drug or resulting Product requiring a response or action by a Party.
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Notification to Other Parties of Regulatory Correspondence. Each Party shall promptly (and in any event, within [***] of the date of receipt of notice) notify the other Party in writing of, and shall provide the other Party with copies of, any correspondence and other documentation received or prepared by such Party in connection with any of the following events: (1) receipt of a regulatory letter, warning letter, or similar item, from the FDA, EMA or any other Regulatory Authority directed to the manufacture, packaging, and/or storage of Bulk or Finished Product or in connection with any general cGMP inspection applicable to any Patheon Facility associated with PATHEON’s Services; (2) any Recall of any Batch of Finished Product from any market in the Relypsa Territory; and (3) any comments from any Regulatory Authority relating to the Services requiring a response or action by a Party.
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Notification to Other Parties of Regulatory Correspondence. Each Party shall promptly (and in any event, within two (2) Business Days of the date of receipt of notice) notify the other Party in writing of, and shall provide the other Party with copies of, any correspondence and other documentation received or prepared by such Party in connection with any of the following events: (i) receipt of a material regulatory letter, warning letter, Form 483, or similar item, from any Regulatory Authority directed to the Manufacture, packaging, and/or storage of Product, any Acerus facility or any contract Manufacturing facility associated with Acerus’ supply of Product hereunder; (ii) any recall or correction of any Batch of Product; and (iii) any regulatory comments relating to Product requiring a response or action by a Party.
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Notification to Other Parties of Regulatory Correspondence. Each Party shall promptly (and in any event, within [*] days of the date of receipt of notice) notify the other Parties in writing of, and shall provide the other Parties with copies of, any correspondence and other documentation received or prepared by such Party in connection with any of the following events: (1) receipt of a regulatory letter, Warning Letter, or similar item, from the FDA, EMEA or any other regulatory authority directed to the manufacture, packaging, and storage of Bulk Drug Substance, Drug Product and/or Finished Product, or in connection with any general cGMP inspections applicable to any BIP facility associated with BIP's activities hereunder; (2) any recall, market withdrawal or correction of any Batch of Bulk Drug Substance, Drug Product and/or Finished Product from any market in the Immunex Territory or Wyeth Territory; and (3) any regulatory comments relating to the manufacture of Bulk Drug Substance, Drug Product and/or Finished Product requiring a response or action by a Party.
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Notification to Other Parties of Regulatory Correspondence. Each Party shall immediately and within at least three (3) business days notify the other Party in writing of, and shall provide the other Party with Table of Contents copies of, any correspondence and other documentation received or prepared by such Party in connection with any of the following events: (i) receipt of a regulatory letter, Warning Letter, or similar item, from the FDA or any other regulatory authority directed to the manufacture, packaging, and storage of Bulk Drug, by Lonza or in connection with any general cGMP inspections applicable to any Lonza Facility to the extent associated with Lonza’s activities under this Agreement; (ii) any recall, market withdrawal or correction of any Batch of Bulk Drug or resulting Finished Product; and (iii) any regulatory comments related to the manufacture of Bulk Drug or resulting Finished Product requiring a response or action by a Party.
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Notification to Other Parties of Regulatory Correspondence. Each Party shall promptly (and in any event, within five (5) Business Days of the date of receipt of notice) notify the other Party in writing of, and shall provide the other Party with copies of, any correspondence and other documentation received or prepared by such Party in connection with any of the following events: (i) receipt of a material regulatory letter, warning letter, Form 483, or similar item, from any Regulatory Authority directed to the manufacture, packaging, and/or storage of a Product, or Alexza facility or contract manufacturing facility associated with Alexza’s supply of Product hereunder; (ii) any recall or correction of any batch of the Drug; and (3) any regulatory comments relating to a Product requiring a response or action by a Party.
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Notification to Other Parties of Regulatory Correspondence. Each Party shall immediately and within one (1) business day notify the other Party in writing of, and shall provide the other Party with copies of, any correspondence and other documentation received or prepared by such Party in connection with any of the following events: (i) receipt of a regulatory letter, warning letter, or similar item, from the FDA or any other Regulatory Agency directed to the manufacture, testing, storage or packaging of Product by Wyeth or in connection with any general cGMP inspections applicable to the Facility; (ii) any recall, market withdrawal or correction of any Batch manufactured, tested, stored, or packaged hereunder or resulting Finished Product, in the case of such Product or Finished Product where the recall, market withdrawal or correction is attributable to any manufacturing, testing, storage, or packaging activities by or on behalf of Wyeth; and (iii) receipt of a regulatory letter, warning letter or similar item from the FDA or any other Regulatory Agency directed to or any regulatory comments related to Product manufactured, tested, stored, or packaged hereunder or resulting Finished Product, in the case of such Product or Finished Product where the comments relate or are attributable to any manufacturing, testing, storage, or packaging activities by or on behalf of Wyeth.
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Related to Notification to Other Parties of Regulatory Correspondence

  • Notification to Other Parties I hereby grant consent to notification by the Company to any other parties besides the Company with whom I maintain a consulting or employment relationship, including parties with whom such relationship commences after the effective date of this Agreement, about my rights and obligations under this Agreement.

  • Notification of Breach / Compliance Reports The Adviser shall notify the Trust immediately upon detection of (i) any material failure to manage any Fund in accordance with its investment objectives and policies or any applicable law; or (ii) any material breach of any of the Funds’ or the Adviser’s policies, guidelines or procedures. In addition, the Adviser shall provide a quarterly report regarding each Fund’s compliance with its investment objectives and policies, applicable law, including, but not limited to the 1940 Act and Subchapter M of the Code, as applicable, and the Fund’s policies, guidelines or procedures as applicable to the Adviser’s obligations under this Agreement. The Adviser agrees to correct any such failure promptly and to take any action that the Board may reasonably request in connection with any such breach. Upon request, the Adviser shall also provide the officers of the Trust with supporting certifications in connection with such certifications of Fund financial statements and disclosure controls pursuant to the Xxxxxxxx-Xxxxx Act. The Adviser will promptly notify the Trust in the event (i) the Adviser is served or otherwise receives notice of any action, suit, proceeding, inquiry or investigation, at law or in equity, before or by any court, public board, or body, involving the affairs of the Trust (excluding class action suits in which a Fund is a member of the plaintiff class by reason of the Fund’s ownership of shares in the defendant) or the compliance by the Adviser with the federal or state securities laws or (ii) an actual change in control of the Adviser resulting in an “assignment” (as defined in the 0000 Xxx) has occurred or is otherwise proposed to occur.

  • Reports; Regulatory Matters (a) The Company and each Company Subsidiary has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2004 with (i) the Federal Reserve Board, (ii) the FDIC, (iii) the Office of the Comptroller of the Currency, (iv) the NASD, (v) any state banking agency, insurance commission or other state regulatory authority, (vi) the SEC, (vii) any foreign regulatory authority and (viii) any SRO (collectively, “Regulatory Agencies”) and with each other applicable Governmental Entity, and all other reports and statements required to be filed by them since January 1, 2004, including any report or statement required to be filed pursuant to the laws, rules or regulations of the United States, any state, any foreign entity, or any Regulatory Agency or Governmental Entity, and have paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by a Regulatory Agency or Governmental Entity in the ordinary course of the business of the Company and its Subsidiaries, no Regulatory Agency or Governmental Entity has initiated since January 1, 2004 or has pending any proceeding, enforcement action or, to the knowledge of the Company, investigation into the business, disclosures or operations of the Company or any Company Subsidiary. Since January 1, 2004, no Regulatory Agency or Governmental Entity has resolved any proceeding, enforcement action or, to the knowledge of the Company, investigation into the business, disclosures or operations of the Company or any Company Subsidiary. There is no unresolved violation, criticism or exception by any Regulatory Agency or Governmental Entity with respect to any report or statement relating to any examinations or inspections of the Company or any Company Subsidiary. Since January 1, 2004, there has been no formal or informal inquiries by, or disagreements or disputes with, any Regulatory Agency or Governmental Entity with respect to the business, operations, policies or procedures of the Company or any Company Subsidiary.

  • 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.

  • Regulatory Reports (a) Since January 1, 2009 Seller has filed or furnished on a timely basis with the Commission all final registration statements, prospectuses, annual, quarterly or current reports and definitive proxy statements or other communications (other than general advertising materials), forms, reports, schedules, statements or other documents required to be filed or furnished by it pursuant to the Securities Act of 1933, as amended (the “1933 Act”), the Securities Exchange Act of 1934, as amended (the “1934 Act”), or the rules and regulations promulgated by the Commission (all such filed or furnished documents, together with all exhibits and schedules thereto and all information incorporated therein by reference, the “Seller SEC Documents”). Seller has previously delivered or made available to Acquiror an accurate and complete copy of each such Seller SEC Document. As of their respective filing dates (and, in the case of registration statements and proxy statements, as of the dates of their effectiveness and the dates of mailing, respectively), except to the extent that any Seller SEC Document has been amended by a subsequently filed Seller SEC Document prior to the date hereof, in which case, as of the date of such amendment, each such final registration statement, prospectus, annual, quarterly or current report and proxy statement or other communication, form, report, schedule, statement or other document, as of its date, complied in all material respects with all applicable Laws (including, without limitation, the 1933 Act, the 1934 Act and the Xxxxxxxx-Xxxxx Act of 2002, as amended) and did not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary in order to make the statements made therein, in light of the circumstances under which they were made, not misleading; provided, that information as of a later date filed publicly shall be deemed to modify information as of an earlier date. To the Knowledge of Seller, there is no fact or circumstance that, individually or in the aggregate, materially and adversely has affected, is so affecting or could reasonably be expected in the future to so affect, the business, financial condition, results of operations or prospects of Seller and Seller Sub, taken individually or as a whole, that is required to be disclosed under the 1933 Act or the 1934 Act but has not been disclosed in such final registration statement, prospectus, annual, quarterly or current reports and definitive proxy statement or other communications, forms, reports, schedules, statements or other documents. None of Seller’s Subsidiaries is required to file periodic reports with the Commission.

  • Right to Review Tax Returns The Responsible Company with respect to any Tax Return shall make such Tax Return and related workpapers available for review by the other Company, if requested, to the extent (a) such Tax Return relates to Taxes for which the requesting party may be liable, (b) such Tax Return relates to Taxes for which the requesting party may be liable in whole or in part or for any additional Taxes owing as a result of adjustments to the amount of Taxes reported on such Tax Return, (c) such Tax Return relates to Taxes for which the requesting party may have a claim for Tax Benefits under this Agreement, or (d) the requesting party reasonably determines that it must inspect such Tax Return to confirm compliance with the terms of this Agreement. The Responsible Company shall make such Tax Return available for review as required under this paragraph at least thirty (30) days prior to the due date for filing such Tax Returns to provide the requesting party with a meaningful opportunity to analyze and comment on such Tax Returns and have such Tax Returns modified before filing. The Companies shall attempt in good faith to resolve any issues arising out of the review of such Tax Returns. Issues that cannot be resolved by the Companies shall be resolved in the manner set forth in Section 14; provided, however, that such Tax Return shall be timely filed in the manner prepared by the Responsible Company if the issues cannot be resolved prior to the time required by law (including extensions) for the filing of such Tax Return.

  • Labor Law Acknowledgement and Policy Statement In accepting the award of Performance Units, you expressly recognize that KBR, Inc., with registered offices at 000 Xxxxxxxxx Xxxxxx, Xxxxx 0000, Xxxxxxx, Xxxxx 00000, U.S.A., is solely responsible for the administration of the Plan and that your participation in the Plan and receipt of Performance Units does not constitute an employment relationship between you and KBR, Inc. since you are participating in the Plan on a wholly commercial basis and your sole employer is KBR in Mexico (“KBR-Mexico”), not KBR, Inc. in the U.S. Based on the foregoing, you expressly recognize that the Plan and the benefits that you may derive from participation in the Plan do not establish any rights between you and your Employer, KBR-Mexico, and do not form part of the employment conditions and/or benefits provided by KBR-Mexico and any modification of the Plan or its termination shall not constitute a change or impairment of the terms and conditions of your employment. You further understand that your participation in the Plan is as a result of a unilateral and discretionary decision of KBR, Inc.; therefore, KBR, Inc. reserves the absolute right to amend and/or discontinue your participation at any time without any liability to you. Finally, you hereby declare that you do not reserve to yourself any action or right to bring any claim against KBR, Inc. for any compensation or damages regarding any provision of the Plan or the benefits derived under the Plan, and you therefore grant a full and broad release to KBR, Inc., its Subsidiary, affiliates, branches, representation offices, its shareholders, officers, agents or legal representatives with respect to any claim that may arise.

  • Regulatory Compliance a. Monitor compliance with the 1940 Act requirements, including:

  • Proxies and Notices; Compliance with the Shareholders Communication Act of 1985 The Custodian shall deliver or cause to be delivered to the appropriate Fund all forms of proxies, all notices of meetings, and any other notices or announcements affecting or relating to Securities owned by such Fund that are received by the Custodian, any Subcustodian, or any nominee of either of them, and, upon receipt of Instructions, the Custodian shall execute and deliver, or cause such Subcustodian or nominee to execute and deliver, such proxies or other authorizations as may be required. Except as directed pursuant to Instructions, neither the Custodian nor any Subcustodian or nominee shall vote upon any such Securities, or execute any proxy to vote thereon, or give any consent or take any other action with respect thereto. The Custodian will not release the identity of any Fund to an issuer which requests such information pursuant to the Shareholder Communications Act of 1985 for the specific purpose of direct communications between such issuer and any such Fund unless a particular Fund directs the Custodian otherwise in writing.

  • Litigation and Regulatory Cooperation During and after the Executive’s employment, the Executive shall cooperate fully with the Company in the defense or prosecution of any claims or actions now in existence or which may be brought in the future against or on behalf of the Company which relate to events or occurrences that transpired while the Executive was employed by the Company. The Executive’s full cooperation in connection with such claims or actions shall include, but not be limited to, being available to meet with counsel to prepare for discovery or trial and to act as a witness on behalf of the Company at mutually convenient times. During and after the Executive’s employment, the Executive also shall cooperate fully with the Company in connection with any investigation or review of any federal, state or local regulatory authority as any such investigation or review relates to events or occurrences that transpired while the Executive was employed by the Company. The Company shall reimburse the Executive for any reasonable out-of-pocket expenses incurred in connection with the Executive’s performance of obligations pursuant to this Section 7(f).

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