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.
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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.
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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.
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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
Termination for Regulatory Action. Ardelyx may terminate this Agreement effective [***] days after delivery of a Notice of Termination for regulatory action if any Regulatory Authority takes any legal action or procedure that prevents Ardelyx from selling the Product in the United States and such market interruption is reasonably expected to last at least [***].
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 Appendix A – Protocol Synopsis Appendix B – Supply of Compound Appendix C – Company Press Release Schedule I – Data Sharing and Sample Testing Schedule 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 collectively as “Parties”.
Sample 1
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Related to Termination for Regulatory Action

  • Regulatory Action (a) If the Executive is removed and/or permanently prohibited from participating in the conduct of the Employer’s affairs by an order issued under Section 8(e)(4) or 8(g)(l) of the Federal Deposit Insurance Act (“FDIA”) (12 U.S.C. 1818(e)(4) and (g)(l)), all obligations of the Employer under this Agreement shall terminate, as of the effective date of such order, except for the payment of Base Salary due and owing under Section 4.1 on the effective date of said order, and reimbursement under Section 4.6 of expenses incurred as of the effective date of termination. (b) If the Executive is suspended and/or temporarily prohibited from participating in the conduct of the Employer’s affairs by a notice served under Section 8(e)(3) or 8(g)(l) of the FDIA (12 U.S.C. 1818(e)(3) and (g)(l)), all obligations of the Employer under this Agreement shall be suspended as of the date of service, unless stayed by appropriate proceedings. If the charges in the notice are dismissed, the Employer shall (i) pay the Executive all or part of the compensation withheld while its contract obligations were suspended and (ii) reinstate (in whole or in part) any of its obligations which were suspended. (c) If the Employer is in default (as defined in Section 3(x)(l) of the FDIA), all obligations under this Agreement shall terminate as of the date of default, but the vested rights of the parties shall not be affected. (d) All obligations under this Agreement shall be terminated, except to the extent a determination is made that continuation of the contract is necessary for the continued operation of the Employer (i) by the director of the Federal Deposit Insurance Corporation (the “FDIC”) or his or her designee (the “Director”), at the time the FDIC enters into an agreement to provide assistance to or on behalf of the Employer under the authority contained in 13(c) of the FDIA; or (ii) by the Director, at the time the Director approves a supervisory merger to resolve problems related to operation of the Employer when the Employer is determined by the Director to be in an unsafe and unsound condition. Any rights of the Executive that have already vested, however, shall not be affected by such action.

  • 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 in Schedule 4.9 of the Buyer Disclosure Schedule, no material litigation, claim, suit, investigation or other proceeding before any court, governmental agency or arbitrator is pending against Buyer or any of its Subsidiaries, and, to the Knowledge of Buyer, (i) no 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. Except as publicly disclosed, neither Buyer nor any of its Subsidiaries has been subject to any order or directive by, or been ordered to pay any civil money penalty by, or has been since January 1, 2019, a recipient of any supervisory letter from, or since January 1, 2019, has adopted any board resolutions at the request of, any Governmental Authority that currently regulates in any material respect the conduct of its business or that in any manner relates to its capital adequacy, its ability to pay dividends, its credit or risk management policies, its management or its business, other than those of general application that apply to similarly-situated banks or financial holding companies or their subsidiaries. (b) Neither Buyer nor any of its Subsidiaries nor any of their respective properties is a party to or is subject to any assistance agreement, board resolution, order, decree, supervisory agreement, memorandum of understanding, condition or similar arrangement with, or a commitment letter or similar submission to, any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits or the supervision or regulation of Buyer or any of its Subsidiaries. (c) Neither Buyer nor any of its Subsidiaries, has been advised by a Governmental Authority that it will issue, or has Knowledge of any facts which would reasonably be expected to give rise to the issuance by any Governmental Authority or has Knowledge that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any such order, decree, agreement, board resolution, memorandum of understanding, supervisory letter, commitment letter, condition or similar submission.

  • 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. (a) If the Executive is suspended from office and/or temporarily prohibited from participating in the conduct of the Bank’s affairs pursuant to notice served under Section 8(e)(3) or Section 8(g)(1) of the Federal Deposit Insurance Act (“FDIA”)(12 U.S.C. §§1818(e)(3) and 1818(g)(1)), the Bank’s obligations under this Agreement shall be suspended as of the date of service, unless stayed by appropriate proceedings. If the charges in the notice are dismissed, the Bank may, in its discretion: (i) pay the Executive all or part of the compensation withheld while its obligations under this Agreement were suspended, and (ii) reinstate (in whole or in part) any of its obligations which were suspended. (b) If the Executive is removed from office and/or permanently prohibited from participating in the conduct of the Bank’s affairs by an order issued under Section 8(e)(4) or Section 8(g)(1) of the 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 the order, but vested rights of the Executive and the Bank as of the date of termination shall not be affected. (c) If the Bank is in default, as defined in Section 3(x)(1) of the FDIA (12 U.S.C. §1813(x)(1)), all obligations under this Agreement shall terminate as of the date of default, but vested rights of the Executive and the Bank as of the date of termination shall not be affected. (d) All obligations under this Agreement shall be terminated pursuant to 12 C.F.R. §563.39(b)(5), except to the extent that it is determined that continuation of the Agreement for the continued operation of the Bank is necessary: (i) by the Director of the OTS, or his/her designee, at the time the Federal Deposit Insurance Corporation (“FDIC”) enters into an agreement to provide assistance to or on behalf of the Bank under the authority contained in Section 13(c) of the FDIA (12 U.S.C. §1823(c)); or (ii) by the Director of the OTS, or his/her designee, at the time the Director or his/her designee approves a supervisory merger to resolve problems related to operation of the Bank or when the Bank is determined by the Director of the OTS to be in an unsafe or unsound condition, but vested rights of the Executive and the Employers as of the date of termination shall not be affected.

  • No Violation, Litigation or Regulatory Action 1. The Company has complied in all material respects with all requirements of any laws or court orders, which are applicable to the business and assets of the Project. 2. There are no lawsuits, claims, suits, proceedings or investigations pending or, to the knowledge of the Company, threatened against or affecting the Company in respect of the assets or the business of the Project nor, to the knowledge of the Company, is there any basis for any of the same, and there is no lawsuit, suit or proceeding pending in which the Company is the plaintiff or claimant which relates to the business or assets of the Project. 3. There is no action, suit or proceeding pending or, to the knowledge of the Company, threatened which questions the legality or propriety of the transactions contemplated by this Agreement. 4. There has been no investigation conducted or charges, complaints or actions brought by the State of Illinois or any governmental body within the State of Illinois (including the Federal government) with respect to the Company or its officers and directors. 5. The Company and its officers and directors have not been the subject of any criminal investigations or charges. 6. The Company would not have Placed in Service the Capital Improvements and created or retained the requisite number of New Employees and Retained Employees without the benefits of the Credit. Proof of this shall include, but is not limited to, correspondence, financial plans and prospectuses, internal memoranda and other written documentation demonstrating the Company would not have taken the actions without the award of the Credit.

  • Absence of Regulatory Actions Since January 1, 2017, neither Purchaser 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 Purchaser 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 Purchaser, 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 Purchaser or its Subsidiaries.

  • PURPOSE/JUSTIFICATION OF RECOMMENDED ACTION The TTC will sell the properties in accordance with the provisions of Division 1, Part 6, Chapter 8 of the Revenue and Taxation Code (R&TC), and the Board of Supervisors' policy adopted on November 24, 1970. Exhibit A of the Chapter 8 Agreement Sale indicates the legal description and selling price of the properties. The Honorable Board of Supervisors 3/5/2019 The recommended action supports County Strategic Plan Strategy III.3 – Pursue Operational Effectiveness, Fiscal Responsibility, and Accountability.

  • 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.

  • Right to Grieve Disciplinary Action Employees shall have the right to grieve written censures or warnings, and adverse employee appraisals. Employees shall have the right to rebut in writing any disciplinary notice and that rebuttal will be placed in the employee file, but will not be part of the formal disciplinary record. Should an employee dispute any such entry in his/her file, he/she shall be entitled to recourse through the Grievance Procedure and the eventual resolution thereof shall become part of his/her personal record.

  • Notice of Disciplinary Action The Employer shall advise an Employee in writing of any disciplinary action taken including, but not limited to warning, reprimand, suspension, discharge or termination and the reasons in full for such action, at the time of taking any such action. The Employer shall also promptly provide the Union with a copy of each such disciplinary notice. If the matter is grieved by the Union, or otherwise litigated in any manner, the Employer shall be limited to those grounds (reasons) specified in the disciplinary notice for the action(s) taken.

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