Termination for Regulatory Action Sample Clauses

Termination for Regulatory Action. Purchaser may terminate this Agreement immediately if FDA or any other Regulatory Authority takes any action, the result of which is to prohibit or restrict the Manufacture, storage, importation, sale, offer for sale or use of the Licensed Adjuvant. Such termination shall not give rise to the payment of any penalty, damages or indemnity by Purchaser.
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Termination for Regulatory Action. Either Party may terminate this Agreement [***] days following written notice to the other Party in the event that any Regulatory Authority takes any action, or raises any objection, that precludes the terminating Party from supplying its Compound for purposes of the Study. Additionally, either Party shall have the right to terminate this Agreement [***] days following written notice to the other Party in the event that it determines in its sole discretion to discontinue development of its Compound, for medical, scientific, legal or other reasons. Section 6.6.
Sample 1
Termination for Regulatory Action. Tetraphase may terminate this Agreement upon thirty (30) days’ prior written notice if any Regulatory Authority takes any action, or raises any objection, that prevents Tetraphase from importing, exporting, purchasing, or selling the Product.
Sample 1
Termination for Regulatory Action. In the event that (i) a Regulatory Authority in a country in the Territory prohibits JCB from Compounding or Commercializing, or mandates a recall with respect to, any Licensed Product in such country, or (ii) [†], then in each case ((i) and (ii)) Omeros may terminate this Agreement in its entirety, with respect to such Licensed Product, or with respect to such country, immediately upon written notice to JCB.
Sample 1
Termination for Regulatory Action. Other Reasons 16 6.6. Termination related to Anti-Corruption Obligations 16 6.7. Return of Merck Compound 16 6.8. Survival 16 6.9. No Prejudice 17 6.10. Confidential Information 17 6.11. Manufacturing Costs 17 7 Costs of Study 17 8 Supply and Use of the Compounds 17 8.1. Supply of the Compounds 17 8.2. Clinical Quality Agreement 18 8.3. Minimum Shelf Life Requirements 18 8.4. Provision of Compounds 18 8.5. Labeling and Packaging; Use, Handling and Storage 19 8.6. Product Specifications 19 8.7. Changes to Manufacturing 19 8.8. Product Testing; Noncompliance 19 8.9. Investigations 21 8.10. Shortage; Allocation 21 8.11. Records; Audit Rights 21 8.12. Quality 21 8.13. Quality Control 21 8.14. Audits and Inspections 21 8.15. Recalls 21 8.16. VAT 21 9 Confidentiality 22 9.1. Confidential Information 22 9.2. Inventions 22 9.3. Personal Identifiable Data 23 10 Intellectual Property 23 10.1. Joint Ownership and Prosecution 23 10.2. Inventions Owned by Company 24 10.3. Inventions Owned by Merck 24 10.4. Mutual Freedom to Operate for Combination Inventions 24 11 Reprints; Rights of Cross-Reference 25 12 Publications; Press Releases 25 12.1. Clinical Trial Registry 25 12.2. Publication 25 12.3. Press Releases 25 13 Representations and Warranties; Disclaimers 26 13.1. Due Authorization 26 13.2. Compounds 26 13.3. Results 26 13.4. Anti-Corruption 26 13.5. DISCLAIMER 28 14 Insurance; Indemnification; Limitation of Liability 28 14.1. Insurance 28 14.2. Indemnification 28 14.3. LIMITATION OF LIABILITY 29 15 Use of Name 30 16 Force Majeure 30 17 Entire Agreement; Amendment; Waiver 30 18 Assignment and Affiliates 30 19 Invalid Provision 30 20 No Additional Obligations 31 21 Governing Law; Dispute Resolution 31 22 Notices 31 23 Relationship of the Parties 32 24 Counterparts and Due Execution 32 Appendices Appendix A – Protocol Synopsis Appendix B – Supply of Compound Appendix C – Company Press Release Schedules Schedule I – Data Sharing and Sample Testing Schedule CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT This CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT (this “Agreement”), is entered into as of May 10, 2017 (the “Effective Date”), by and among MSD International GmbH, having a place of business at Wxxxxxxxxx 00, 0000 Xxxxxx 0, Xxxxxxxxxxx (“Merck”), and OncoSec Medical Incorporated, having a place of business at 5000 Xxxxx Xxxxx Drive, San Diego, California 92121 USA (“Company”). Merck and Company are each referred to herein individually as “Party” and collective...
Sample 1
Termination for Regulatory Action. In the event that (a) Company fails to obtain or maintain all Regulatory Approvals necessary for the conduct of the Gilead Arm (other than Manufacturing Approvals for the Gilead Compound) or (b) a Regulatory Authority takes any action or makes any recommendation (i) to suspend or terminate the Gilead Arm, (ii) to require the conduct of additional studies with respect to the Combination Therapy (or any Compound) prior to or in connection with the conduct of the Gilead Arm or (iii) that would prevent one of the Parties from supplying its Compound for the Gilead Arm, the Parties shall meet promptly to discuss such matter in good faith and consider potential steps to address such failure, action or recommendation. If the Parties are not able to agree upon such steps within [***] days after commencement of such discussions, then either Party may terminate this Agreement effective immediately upon written notice to the other Party.
Sample 1

Related to Termination for Regulatory Action

  • Regulatory Action (a) If Executive is removed and/or permanently prohibited from participating in the conduct of the Bank’s affairs by an order issued under Section 8(e)(4) or 8(g)(1) of the Federal Deposit Insurance Act (“FDIA”) (12 U.S.C. 1818(e)(4) and (g)(1)), all obligations of the Bank under this Agreement shall terminate, as of the effective date of such order.

  • Notice of Regulatory Action To the extent permitted by applicable Law, each Seller shall promptly notify the applicable Purchaser of any action, claim, inquiry, audit, investigation or examination taken or made by a Government Authority that may affect the conduct of a Serviced Appointment and shall consult with such Purchaser as to any changes in duties or other arrangements hereunder to be taken in connection therewith.

  • Litigation; Regulatory Action (a) Except as set forth on Schedule 3.10 of the Company Disclosure Schedule, no litigation, claim, suit, investigation or other proceeding before any court, governmental agency or arbitrator is pending against the Company or any of its Subsidiaries, and, to the Knowledge of the Company, (i) no such litigation, claim, suit, investigation or other proceeding has been threatened and (ii) there are no facts which would reasonably be expected to give rise to such litigation, claim, suit, investigation or other proceeding.

  • Regulatory Actions The following provisions shall be applicable to the parties to the extent that they are required to be included in employment agreements between a savings bank and its employees pursuant to Section 563.39(b) of the Office of Thrift Supervision (“OTS”) Rules and Regulations, 12 C.F.R. §563.39(b), or any successor thereto, and shall be controlling in the event of a conflict with any other provision of this Agreement, including without limitation Section 5 hereof.

  • No Violation, Litigation or Regulatory Action Except as set forth in Schedule 6.3:

  • Absence of Regulatory Actions Since January 1, 2017, neither the Company nor any of its Subsidiaries has been a party to any cease and desist order, written agreement or memorandum of understanding with, or any commitment letter or similar undertaking to, or has been subject to any action, proceeding, order or directive by any Governmental Entity, or has adopted any board resolutions relating to such matters as are material to the business of the Company or its Subsidiaries at the request of any Governmental Entity, or has been advised by any Governmental Entity that it is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any such action, proceeding, order, directive, written agreement, memorandum of understanding, commitment letter, board resolutions or similar undertaking. To the Knowledge of the Company, there are no material unresolved violations, criticisms or exceptions by any Governmental Entity with respect to any report or statement relating to any examinations of the Company or its Subsidiaries.

  • 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.

  • Notification of Threatened Action Each Party will immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by any Regulatory Authority, which may affect the safety or efficacy claims of any Licensed Product or the continued marketing of any Licensed Product. Upon receipt of such information, the Parties will consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.

  • ABSENCE OF LITIGATION AND/OR REGULATORY PROCEEDINGS Except as set forth in the SEC Documents, there is no action, suit, proceeding, inquiry or investigation before or by any court, public board, government agency, self-regulatory organization or body pending or, to the knowledge of the executive officers of Company or any of its Subsidiaries, threatened against or affecting the Company, the Common Stock or any of the Company’s Subsidiaries or any of the Company’s or the Company’s Subsidiaries’ officers or directors in their capacities as such, in which an adverse decision could have a Material Adverse Effect.

  • No Action by Administrator Notwithstanding anything to the contrary in this Agreement, the Administrator shall not be obligated to, and shall not, take any action that the Issuer directs the Administrator not to take or which would result in a violation or breach of the Issuer’s covenants, agreements or obligations under any of the Issuer Documents.

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