Termination for Failure to Receive Regulatory Approval Sample Clauses

Termination for Failure to Receive Regulatory Approval. In the event that the Licensed Product does not receive Regulatory Approval from the FDA in the Territory on or before Xxxxx 00, 0000, Xxxxxxxx may, in its sole discretion, terminate this Agreement immediately upon delivery of written notice to Sol-Gel no later than thirty (30) days after such date.
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Termination for Failure to Receive Regulatory Approval. This Agreement will, upon written notice from Stealth or the Majority Investors (on behalf of all Investors) to the other, terminate with no further action from any Party following either (a) the failure of the Product to receive Regulatory Approval in at least one of the Designated Indications within five (5) years after the occurrence of the Tranche 3 Milestone Event, despite exercise of Commercially Reasonable Efforts, or (b) the reasonable determination of the Major Investors that the Research Results do not support Regulatory Approval in the Territory due to the Trials’ failure to achieve the primary endpoints. For avoidance of doubt, if an application for Regulatory Approval is submitted to one, but not both, of FDA or the EMA, then this Agreement shall not be terminated pursuant to this Section 10.2.4.
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Termination for Failure to Receive Regulatory Approval. Pacira may terminate this Agreement (i) with respect to the United States and each country in the European Union, on a county-by-country basis on [***] calendar days’ written notice in the event Aratana does not obtain Regulatory Approval for the Licensed Product in such country within [***] years of the Effective Date, or (ii) with respect to jurisdictions other than the United States and European Union (the “Other Jurisdictions”) on a country by country basis on [***] calendar days’ written notice; if Aratana has not commenced Development and dosed its first patient/subject in support of obtaining Regulatory Approval for the Licensed Product in the Other Jurisdictions within [***] years of the Effective Date.
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Termination for Failure to Receive Regulatory Approval. 14.2.3.1 This Agreement will, upon written notice from either Party to the other Party, terminate with no further action from either Party if the Product has failed to 44 receive Regulatory Approval from both the FDA and the EMA after completion of the Trial, submission by Apellis of applications for Regulatory Approval to the FDA and the EMA and after Commercially Reasonable Efforts by Apellis to obtain such Regulatory Approvals based on such submitted applications. For the avoidance of doubt, if Regulatory Approval is received from either the FDA or the EMA, then this Agreement shall not be terminated pursuant to this Section 14.2.3.1.
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Termination for Failure to Receive Regulatory Approval. AMAG shall have the right, but not the obligation, to terminate this Agreement if the Product does not receive Regulatory Approval in the Licensed Territory within [***] after the Effective Date.
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Termination for Failure to Receive Regulatory Approval. 14.2.4.1 This Agreement will, upon written notice from either Party to the other Party, terminate with no further action from either Party if the Product has not received Regulatory Approval from at least one of (i) the FDA, (ii) EMA, (iii) PMDA, or (iv) NMPA after completion of the Clinical Trials, submission by PB of applications for Regulatory Approval to the FDA and EMA, and submission by SFJ of applications for Regulatory Approval to the PMDA and NMPA, and after Commercially Reasonable Efforts to obtain such Regulatory Approvals based on such submitted applications as may be amended from time to time. For the avoidance of doubt, if Regulatory Approval is received from any of the FDA, EMA, PMDA, or NMPA then this Agreement may not thereafter be terminated pursuant to this Section 14.2.4.1.
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Termination for Failure to Receive Regulatory Approval. In the event that the Licensed Product does not receive Regulatory Approval from the FDA in the Territory on or before [***], Galderma may, in its sole discretion, terminate this Agreement immediately upon delivery of written notice to Sol-Gel no later than [***] after such date.
Sample 1
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Termination for Failure to Receive Regulatory Approval. 13.2.3.1 This Agreement will, upon written notice from either Party to the other Party, terminate with no further action from either Party if the Product has not received Regulatory Approval from the FDA for any of the Indications after completion of the Clinical Trials, submission by Nektar or BMS, as applicable, of applications for Regulatory Approvals to the FDA, and after Commercially Reasonable Efforts by Nektar to obtain such Regulatory Approvals based on such submitted applications as may be amended from time to time. For the avoidance of doubt, if Regulatory Approval for any Indication or any Other Indication is received from the FDA, then his Agreement may not thereafter be terminated pursuant to this Section 13.2.3.1.
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Termination for Failure to Receive Regulatory Approval 
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Related to Termination for Failure to Receive Regulatory Approval

  • Notification of Breach The Seller will advise the Issuer promptly, in reasonable detail, upon discovery of the occurrence of any breach in any material respect by the Seller of any of its representations, warranties and covenants contained herein or in any other Transaction Documents (and the Issuer promptly shall forward such notice to the Administrative Agent and the Indenture Trustee).

  • Termination for Material Breach If either Party (the “Non-Breaching Party”) believes that the other Party (the “Breaching Party”) has materially breached one or more of its material obligations under this Agreement, then the Non-Breaching Party may deliver notice of such material breach to the Breaching Party (a “Default Notice”). If the Breaching Party does not dispute that it has committed a material breach of one or more of its material obligations under this Agreement, then if the Breaching Party fails to cure such breach within *** days after receipt of the Default Notice, or if such compliance cannot be fully achieved through diligent efforts within such *** day period but the Breaching Party has failed to promptly commence compliance or has failed to use diligent efforts to achieve full compliance as soon thereafter as is reasonably possible, or if full compliance is not achieved in any event within *** days after receipt of the Default Notice, then the Non-Breaching Party may terminate this Agreement upon written notice to the Breaching Party. If the Breaching Party disputes that it has materially breached one or more of its material obligations under this Agreement, the dispute shall be resolved pursuant to Section 11.7. If, as a result of the application of such dispute resolution procedures, the Breaching Party is determined to be in material breach of one or more of its material obligations under this Agreement (an “Adverse Ruling”), then if the Breaching Party fails to cure any breach specified by the Adverse Ruling within *** days after such ruling, or if such compliance cannot be fully achieved through diligent efforts within such *** day period but the Breaching Party has failed to promptly commence compliance or has failed to use diligent efforts to achieve full compliance as soon thereafter as is reasonably possible, or if full compliance is not achieved in any event within *** days after the Adverse Ruling, then the Non-Breaching Party may terminate this Agreement upon written notice to the Breaching Party.

  • 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.

  • Notification of Error The Trust will notify USBFS of any discrepancy between USBFS and the Trust, including, but not limited to, failing to account for a security position in the Fund’s portfolio, upon the later to occur of: (i) three business days after receipt of any reports rendered by USBFS to the Trust; (ii) three business days after discovery of any error or omission not covered in the balancing or control procedure; or (iii) three business days after receiving notice from any shareholder regarding any such discrepancy.

  • Notification of Required or Unauthorised Disclosure You agree (to the extent permitted by law) to inform us of the full circumstances of any disclosure under paragraph 2(b) or upon becoming aware that Confidential Information has been disclosed in breach of this letter.

  • Investigation of Breach If the Seller (i) has knowledge of a breach of a representation or warranty made in Section 3.4, (ii) receives notice from the Depositor, the Trust, the Owner Trustee or the Indenture Trustee of a breach of a representation or warranty made in Section 3.4, (iii) receives a written request to repurchase a Receivable due to an alleged breach of a representation and warranty in Section 3.4 from the Owner Trustee, the Indenture Trustee, any Verified Note Owner or any Noteholder (which repurchase request shall provide sufficient detail so as to allow the Seller to reasonably investigate the alleged breach of the representations and warranties in Section 3.4; provided, that with respect to a repurchase request from a Noteholder or a Verified Note Owner, such repurchase request shall initially be provided to the Indenture Trustee) for a Receivable (each, a “Repurchase Request”) or (iv) receives a final report from the Asset Representations Reviewer that indicates that the Asset Representations Reviewer has determined that a test procedure under the Asset Representations Review Agreement has not been satisfied with respect to a representation or warranty set forth in Section 3.4 for a Receivable, then, in each case, the Seller will investigate the Receivable to confirm the breach and determine if the breach materially and adversely affects the interests of the Purchaser, the Issuer or the Noteholders in any Receivable. None of the Servicer, the Issuer, the Owner Trustee, the Indenture Trustee, the Asset Representations Reviewer or the Administrator will have an obligation to investigate whether a breach of any representation or warranty has occurred or whether any Receivable is required to be repurchased under this Section 3.5.

  • Termination of Requirement Cash Collateral (or the appropriate portion thereof) provided to reduce Issuing Bank’s Fronting Exposure shall no longer be required to be held as Cash Collateral pursuant to this Section 2.19 following (i) the elimination of the applicable Fronting Exposure (including by the termination of Defaulting Lender status of the applicable Lender) or (ii) the determination by Administrative Agent and the Issuing Banks that there exists excess Cash Collateral; provided that, subject to the other provisions of this Section 2.19, the Person providing Cash Collateral and each Issuing Bank may agree that Cash Collateral shall be held to support future anticipated Fronting Exposure; provided, further, that to the extent that such Cash Collateral was provided by Borrower, such Cash Collateral shall remain subject to the security interest granted pursuant to the Loan Documents.

  • Notice of Material Actions / Change in Control The Sub-Adviser will keep the Trust and the Adviser informed of developments relating to its duties as subadviser of which the Sub-Adviser has, or should have, knowledge that would materially affect the Fund. The Sub-Adviser will promptly notify the Adviser in writing of the occurrence of any of the following events (i) it is served or otherwise receives notice of, or is threatened with, any material action, suit, proceeding, inquiry or investigation, at law or in equity, before or by any court, governmental, administrative or self-regulatory agency, or public board or body, involving the affairs of the Fund and (ii) any change in the partners of the Sub-Adviser or in the actual control or management of the Sub-Adviser or change in the portfolio manager(s) primarily responsible for the day-to-day management of the Allocated Portion.

  • License of Data; Warranty; Termination of Rights A. The valuation information and evaluations being provided to the Trust by USBFS pursuant hereto (collectively, the “Data”) are being licensed, not sold, to the Trust. The Trust has a limited license to use the Data only for purposes necessary to valuing the Trust’s assets and reporting to regulatory bodies (the “License”). The Trust does not have any license nor right to use the Data for purposes beyond the intentions of this Agreement including, but not limited to, resale to other users or use to create any type of historical database. The License is non-transferable and not sub-licensable. The Trust’s right to use the Data cannot be passed to or shared with any other entity. The Trust acknowledges the proprietary rights that USBFS and its suppliers have in the Data.

  • Notification of Material Events The Company, during the period when the Prospectus is (or but for the exemption in Rule 172 would be) required to be delivered under the 1933 Act or the 1934 Act, shall notify the Representatives of the occurrence of any material events respecting its (including those of the Operating Partnership) activities, affairs or condition, financial or otherwise, if, but only if, as a result of any such event it is necessary, in the opinion of counsel, to amend or supplement the Prospectus in order to make the Prospectus not misleading in the light of the circumstances existing at the time it is (or but for the exemption in Rule 172 would be) delivered to a purchaser, and the Company will forthwith supply such information as shall be necessary in the opinion of counsel to the Company and the Underwriters for the Company to prepare any necessary amendment or supplement to the Prospectus so that, as so amended or supplemented, the Prospectus will not contain an untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances existing at the time it is (or but for the exemption in Rule 172 would be) delivered to a purchaser, not misleading.

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