Adverse Changes; Changes Requiring New FDA Approval of NDA or NDA Supplement Sample Clauses

Adverse Changes; Changes Requiring New FDA Approval of NDA or NDA Supplement. Profile shall not, without the prior written consent of CoTherix, make or incorporate in any AAD Device or Consumable provided under this Agreement, any process, design or other change which (a) adversely affects the intended use, function or quality of such AAD Device or Consumable or (b) affects the approval of the Ventavis NDA or any supplement thereto (with each of the foregoing changes being referred to herein as a “Significant Change”). If Profile wishes to make a Significant Change to an AAD Device or Consumable, Profile shall give CoTherix prior written notice of such proposed Significant Change (“Proposed Significant Change”), which notice (a “Proposed Significant Change Notice”) shall contain a detailed description of the Proposed Significant Change and shall be accompanied by one or more evaluation samples. If CoTherix consents to the Proposed Significant Change, Profile shall be responsible for obtaining from the FDA any clearances needed in order to sell AAD Devices and/or Consumables containing a Proposed Significant Change, and CoTherix shall be responsible for obtaining from the FDA any approvals needed to distribute Ventavis with AAD Devices and/or Consumables containing a Proposed Significant Change, with the cost of obtaining the FDA approvals needed by CoTherix to be shared by the parties in the amounts and in the manner mutually agreed to by the parties. Profile shall not sell to CoTherix or the Specialty Pharmacy Company any AAD Devices or Consumables containing a Proposed Significant Change until all of the following have occurred: (a) CoTherix has consented in writing to the Proposed Significant Change, (b) all necessary FDA clearances have been obtained by Profile, and (c) all necessary FDA approvals have been obtained by CoTherix. Unless and until all of the foregoing conditions have been satisfied, the then-existing version of AAD Devices and Consumables being sold to CoTherix and the Specialty Pharmacy Company under this Agreement shall continue to be supplied to CoTherix and the Specialty Pharmacy Company pursuant to the terms of this Agreement. Both Profile and CoTherix shall act promptly, following the consent by CoTherix to a Proposed Significant Change, to obtain any necessary clearances and approvals from the FDA with respect to the Proposed Significant Change. For purposes of clarification, the refusal of CoTherix to consent to a Proposed Significant Change or the failure of the FDA to approve delivery of Ventavis with an...
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Related to Adverse Changes; Changes Requiring New FDA Approval of NDA or NDA Supplement

  • Material Changes or Material Transactions Since the respective dates as of which information is given in the Registration Statement and the Prospectus, except as may otherwise be stated therein or contemplated thereby, there has been no material adverse change in the condition, financial or otherwise, or in the earnings, business affairs or business prospects of the Company and its subsidiaries considered as one enterprise, whether or not arising in the ordinary course of business.

  • Description of Change in Terms A. Modification(s) to Loan Agreement.

  • Notification of Changes Subscriber agrees and covenants to notify the Company immediately upon the occurrence of any event prior to the consummation of this Offering that would cause any representation, warranty, covenant or other statement contained in this Agreement to be false or incorrect or of any change in any statement made herein occurring prior to the consummation of this Offering.

  • Certain Accounting Changes; Organizational Documents (a) Change its Fiscal Year end, or make any change in its accounting treatment and reporting practices except as required by GAAP, as set forth in Section 13.9 or as recommended by the Securities Exchange Commission or the Public Company Accounting Oversight Board or (b) amend, modify or change its articles of incorporation (or corporate charter or other similar organizational documents) or amend, modify or change its bylaws (or other similar documents) in any manner adverse in any respect to the rights or interests of the Lenders.

  • Effect of Change of Control Upon a Change of Control, a number of Units shall, upon certification of performance by the Committee, convert into time-based restricted stock units (the “Time-Based Units”) calculated based on a performance period from January 1, 2021 through the end of the fiscal quarter immediately preceding the closing date of the transaction giving rise to the Change of Control; and provided further that the Date of Issuance in such case shall be December 31, 2023 subject to either (1) your continued employment through such date or (2) your Retirement, pursuant to Section 3(b)(iii). Upon your termination of employment by Capital One without Cause or for Good Reason (each as defined below), in either case on or prior to the second anniversary of the occurrence of a Change of Control of Capital One and prior to the Date of Issuance with respect to the Time-Based Units, then notwithstanding anything herein to the contrary, all of the Time-Based Units shall vest and the Shares shall be issuable in full without restrictions on transferability immediately upon the occurrence of your termination of employment following such Change of Control (to the extent not previously vested or forfeited as provided herein) and such date shall be the Date of Issuance; provided, however, that if the Time-Based Units are considered deferred compensation under Section 409A of the Code and not exempt from Section 409A of the Code as a short-term deferral or otherwise, and you are a “specified employee,” as defined in and pursuant to Reg. Section 1.409A 1(i) or any successor regulation, on the date of any such termination of employment without Cause or for Good Reason, you will not be entitled to such vesting earlier than the earlier of (i) the date which is six months from the date of your “separation from service” (as defined in Reg. Section 1.409A 1(h) or any successor regulation) as a result of such termination and (ii) your death. With respect to any Time-Based Units that have vested, the Shares related thereto shall be issued to you, in settlement of such vested Time-Based Units, on the Date of Issuance. Dividends will be accrued and paid out as additional shares at the time of the award, as provided in Section 6 below. All Time-Based Units, including your rights thereto and to the underlying Shares, which do not vest on or before the Date of Issuance, as provided in this Section 3, shall immediately be forfeited as of such Date of Issuance (to the extent not previously forfeited as provided herein).

  • No Effect Prior to Change in Control This Agreement shall not effect any rights of the Company to terminate the Executive prior to a Change in Control or any rights of the Executive granted in any other agreement or contract or plan with the Company. The rights, duties and benefits provided hereunder shall only become effective upon and after a Change in Control. If the full-time employment of the Executive by the Company is ended for any reason prior to a Change in Control, this Agreement shall thereafter be of no further force and effect.

  • Revocation Effect and Solicitation of Consents Special Record Dates Etc 60 Section 9.05. Notations and Exchanges. 61 Section 9.06. Trustee to Execute Supplemental Indentures. 61 Article 10. Satisfaction and Discharge 61 Section 10.01. Termination of Company’s Obligations. 61 Section 10.02. Repayment to Company. 62 Section 10.03. Reinstatement. 62 Article 11. Collateral Agency 63 Section 11.01. Collateral Agent. 63 Section 11.02. Application Proceeds of any Collateral. 63 Section 11.03. Limitation on the Duty of Collateral Agent in Respect of Collateral. 63 Article 12. Collateral And Security 65 Section 12.01. General. 65 Section 12.02. Security Documents. 65 Section 12.03. [Reserved]. 66 Section 12.04. Possession, Use and Release of Collateral. 66 Section 12.05. Suits to Protect Collateral. 67 Section 12.06. Powers Exercisable by Receiver, Trustee or Collateral Agent. 67 Section 12.07. Determinations Relating to Collateral. 67 Section 12.08. [Reserved]. 68 Section 12.09. [Reserved]. 68 Section 12.10. Purchaser Protected. 68 Article 13. Trustee 68 Section 13.01. Duties of Trustee. 68 Section 13.02. Rights of Trustee. 69 Section 13.03. Individual Rights of Trustee. 71 Section 13.04. Trustee’s Disclaimer. 71 Section 13.05. [Reserved]. 71 Section 13.06. [Reserved]. 71 Section 13.07. Compensation and Indemnity. 71 Section 13.08. Replacement of Trustee. 72 Section 13.09. Successor Trustee by Xxxxxx, Etc. 73 Section 13.10. [Reserved]. 73 Section 13.11. [Reserved]. 74 ||| Article 14. Miscellaneous 74 Section 14.01. Notices. 74 Section 14.02. Delivery of Officer’s Certificate and Opinion of Counsel as to Conditions Precedent. 75 Section 14.03. Statements Required in Officer’s Certificate and Opinion of Counsel. 76 Section 14.04. Rules by the Trustee, the Registrar and the Paying Agent. 76

  • Term and Effect Prior to Change in Control (a) Except as otherwise provided herein, the term of this Agreement shall include: (i) the period commencing on the Effective Date and ending December 31, 2023, plus (ii) any and all extensions of the term made pursuant to paragraphs (b) and (c) of this Section 4 (the “Term”).

  • Term SOFR Conforming Changes In connection with the use or administration of Term SOFR, the Administrative Agent will have the right to make Conforming Changes from time to time and, notwithstanding anything to the contrary herein or in any other Loan Document, any amendments implementing such Conforming Changes will become effective without any further action or consent of any other party to this Agreement or any other Loan Document. The Administrative Agent will promptly notify the Borrower and the Lenders of the effectiveness of any Conforming Changes in connection with the use or administration of Term SOFR.

  • Implementation of Corrective Action Plan After the Corrective Action Plan is finalized, the Purchasers shall use reasonable best efforts to implement the finalized Corrective Action Plan on the timeline set forth therein and provide periodic reports (as provided for therein) to the Sellers on the status of their implementation of the Corrective Action Plan.

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