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.
Sample 1
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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.
Sample 1
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.
Sample 1
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. 14.2.4.2 This Agreement will, upon written notice from either Party to the other Party, terminate with no further action from either Party, if the Phase 3 Trial is completed or terminated and either (a) the primary endpoint in the Phase 3 Trial is not achieved or (b) SFJ reasonably determines that the Research Results of the Phase 3 Trial do not support Regulatory Approval. For avoidance of doubt, if an application for Regulatory Approval is submitted to any of the FDA, EMA, PMDA or NMPA then this Agreement may not thereafter be terminated pursuant to this Section 14.2.4.2. 14.2.4.3 In the event that this Agreement is terminated pursuant to this Section 14.2.4, then, if PB elects to continue development of the Product and obtains Regulatory Approval following such termination, in exchange for purchasing the Trial Data Package including the Research Results included therein as set forth in Section 11.1.1.4, PB shall remain obligated to make any Approval Payments that become due and payable pursuant to ARTICLE 6 at such time that such payments become due and payable (if ever) pursuant to ARTICLE 6 (except to the extent of the amount of any Buy-Out Payment paid by PB pursuant to Section 6.7), provided that such Approval Payments (or Buy-Out Payment, as applicable) shall be adjusted as set forth in Section 6.2.
Sample 1
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 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. 14.2.3.2 This Agreement will, upon written notice from either Party to the other Party, terminate with no further action from either Party if either (1) the primary endpoint in the PEGASUS Trial has not been achieved or (2) the mutual agreement of Apellis and SFJ that the Research Results do not support Regulatory Approval and that an application for Regulatory Approval shall not be submitted to either the FDA or the EMA. 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 14.2.3.2.
Sample 1
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.
Sample 1
Termination for Failure to Receive Regulatory Approval. 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.
Sample 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
Termination for Failure to Receive Regulatory Approval 
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Related to Termination for Failure to Receive Regulatory Approval

  • Notification of Recall Notification of recall from layoff shall be sent by certified mail, return receipt requested, deliverable to addressee only, to the employee's last known address. The notice shall give the employee a minimum of ten (10) calendar days within which to respond after the notice of recall has been mailed. Employees who decline recall or who, in the absence of extenuating circumstances, fail to respond within the time set for return to work, shall be presumed to have resigned and their name shall be removed from the seniority and preferred eligibility list.

  • Notification of Breach During the term of this Agreement:

  • Termination for Material Breach Either Party (the “Terminating Party”) may terminate this Agreement in its entirety, or on a country-by-country and Product-by-Product basis, in the event the other Party (the “Breaching Party”) has materially breached this Agreement, and such material breach has not been cured within sixty (60) days after receipt of written notice of such breach by the Breaching Party from the Terminating Party (the “Cure Period”). The written notice describing the alleged material breach shall provide sufficient detail to put the Breaching Party on notice of such material breach. Any termination of this Agreement pursuant to this Section 10.3 shall become effective at the end of the Cure Period, unless the Breaching Party has cured any such material breach prior to the expiration of such Cure Period; provided that in the event a claim of material breach is being contested diligently and in good faith by appropriate proceedings hereunder, any termination pursuant to this Section shall not become effective unless and until such material breach has been established in such proceedings and, in the event that, following such establishment, a cure may then be accomplished by the payment of money or the taking of certain actions, such payment or actions are not paid or taken within sixty (60) days of the conclusion of such proceedings. The right of either Party to terminate this Agreement as provided in this Section 10.3 shall not be affected in any way by such Party’s waiver of or failure to take action with respect to any previous breach under this Agreement.

  • Independence from Material Breach Determination Except as set forth in Section X.D.1.c, these provisions for payment of Stipulated Penalties shall not affect or otherwise set a standard for OIG’s decision that Xxxxx has materially breached this IA, which decision shall be made at OIG’s discretion and shall be governed by the provisions in Section X.D, below.

  • 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.

  • New Application for Licensure Any time after the three-month period has lapsed from the Effective Date of this Agreement and Respondent has paid the Administrative Penalty set forth in Section III, Paragraph 1 of this Order, Respondent may apply for a new mortgage loan originator license or, as applicable, petition for the reinstatement of an MLO Activity Endorsement in any or all of the Participating States with the understanding that each State Mortgage Regulator reserves the rights to fully investigate such application for licensure or petition for reinstatement of an MLO Activity Endorsement and may either approve or deny such application or petition pursuant to the normal process for such licensing or endorsement investigations. No license application or petition described in this paragraph will be denied solely based on the facts, circumstances, or consensual resolution provided for in this Agreement. Respondent further agrees that Respondent must satisfy the Administrative Penalty provision prior to submitting an application for a new mortgage loan originator license or, as applicable, petition for the reinstatement of an MLO Activity Endorsement.

  • Termination Due To Lack Of Funding Appropriation If, in the judgment of the Director of Accounts and Reports, Department of Administration, sufficient funds are not appropriated to continue the function performed in this agreement and for the payment of the charges hereunder, State may terminate this agreement at the end of its current fiscal year. State agrees to give written notice of termination to contractor at least 30 days prior to the end of its current fiscal year, and shall give such notice for a greater period prior to the end of such fiscal year as may be provided in this contract, except that such notice shall not be required prior to 90 days before the end of such fiscal year. Contractor shall have the right, at the end of such fiscal year, to take possession of any equipment provided State under the contract. State will pay to the contractor all regular contractual payments incurred through the end of such fiscal year, plus contractual charges incidental to the return of any such equipment. Upon termination of the agreement by State, title to any such equipment shall revert to contractor at the end of the State's current fiscal year. The termination of the contract pursuant to this paragraph shall not cause any penalty to be charged to the agency or the contractor.

  • Notification of Compromise or Potential Compromise The compromise or potential compromise of Confidential Information must be reported to the DSHS Contact designated on the contract within one (1) business day of discovery. Contractor must also take actions to mitigate the risk of loss and comply with any notification or other requirements imposed by law or DSHS.

  • 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.

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