Amendments, Changes and Approvals Sample Clauses

Amendments, Changes and Approvals. Either Party (through its representatives on the JDT after the JDT is formed), may propose amendments to the Relay Phase Ia Plan at any time until such time as no further Development activities are occurring or expected to occur under such Relay Phase Ia Plan. No amendment or material change to the Relay Phase Ia Plan, including any change to the protocol or investigator’s brochure, will be effective unless and until approved by the JDT. Notwithstanding the foregoing, in the event Licensee desires to amend the Relay Phase Ia Plan to add an additional clinical or non-clinical study to the Relay Phase Ia Plan that is not required nor requested by a Regulatory Authority (each, an “Optional Additional Phase Ia Study”), then Licensee will submit the Optional Additional Phase Ia Study to Relay (through the JDT after the JDT is formed) for consideration. If Relay agrees to the addition of the Optional Additional Phase Ia Study to the Relay Phase Ia Plan, then the Relay Phase Ia Plan will be amended to add such Optional Additional Phase Ia Study at Licensee’s cost. If Relay does not agree to the addition of the Optional Additional Phase Ia Study to the Relay Phase Ia Plan, then Licensee may conduct such Optional Additional Phase Ia Study at its own expense outside of the Relay Phase Ia Plan. If during the conduct of the Relay Phase Ia Trial a Regulatory Authority requires that an additional clinical or non-clinical study be conducted or otherwise requires an amendment to the protocol for the Relay Phase Ia Trial (a “Required Additional Phase Ia Study”), then the Parties will amend the Relay Phase Ia Plan to add such Required Additional Phase Ia Study [***]. If during the conduct of the Relay Phase Ia Trial a Regulatory Authority requests but does not require an additional clinical or non-clinical study be conducted or otherwise requests but does not require an amendment to the protocol for the Relay Phase Ia Trial (a “Requested Additional Phase Ia Study”), the Parties will, through the JDT, discuss in good faith whether the Requested Additional Phase Ia Study can and should be conducted as part of and with the same patient population as the existing or planned Relay Phase Ia Trial, or whether it should be conducted as a separate study by Licensee, taking into consideration strategic factors and timing and resource considerations. [***]. It is understood that time is of the essence in Relay’s ability to conduct the Relay Phase Ia Plan, and that no decisions of the ...
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Related to Amendments, Changes and Approvals

  • Amendments, changes and supplements Any amendment, change and supplement to this Agreement shall require the execution of a written agreement by all of the Parties.

  • Amendments; Consents and Waivers No modification, amendment or waiver of, or with respect to, any provision of this Agreement, and all other agreements, instruments and documents delivered thereto, nor consent to any departure by the Seller from any of the terms or conditions thereof shall be effective unless it shall be in writing and signed by each of the parties hereto, the written consent of the Indenture Trustee on behalf of the Noteholders is given and confirmation from each Rating Agency that such action will not result in a downgrade, withdrawal or qualification of any rating assigned to a Class of Notes is received. The Seller shall provide the Indenture Trustee and each Rating Agency with such proposed modifications, amendments or waivers. Any waiver or consent shall be effective only in the specific instance and for the purpose for which given. No consent to or demand by the Seller in any case shall, in itself, entitle it to any other consent or further notice or demand in similar or other circumstances. The Seller acknowledges that in connection with the intended assignment by the Depositor of all of its right, title and interest in and to each Timeshare Loan to the Issuer, the Issuer intends to issue the Notes, the proceeds of which will be used by the Issuer to purchase the Timeshare Loans from the Depositor under the terms of the Sale Agreement.

  • Amendments, Changes and Modifications This Agreement may be amended, changed, modified, altered or terminated only by written instrument or written instruments signed by all of the parties hereto.

  • Amendments, Supplements and Waivers Section 9.01.

  • Consents Amendments and Waivers Any term of this Agreement may be amended, and the observance of any term hereof may be waived (either generally or in a particular instance), only with the written consent of the 63% in Interest Purchasers and the written consent of the Company. Any amendment or waiver effected in accordance with this Section 8.8 shall be binding upon each of the parties hereto.

  • Amendments; Consents No amendment, modification, termination, or waiver of any provision of any Loan Document nor consent to any variance therefrom, shall be effective unless the same shall be in writing and signed by the Required Banks and then such waiver or consent shall be effective only in the specific instance and for the specific purpose for which given. Anything herein to the contrary notwithstanding, unanimous consent of the Banks shall be required with respect to (a) any increase in the Commitment hereunder, (b) the extension of maturity of the Notes, the payment date of interest or principal thereunder, or the payment of commitment or other fees or amounts payable hereunder, (c) any reduction in the rate of interest on the Notes, or in any amount of principal or interest due on any Note, or the payment of commitment or other fees hereunder or any change in the manner of pro rata application of any payments made by Borrower to the Banks hereunder, (d) any change in any percentage voting requirement, voting rights, or the Required Banks definition in this Agreement, (e) the release of any Guarantor of Payment except for the release of a Guarantor of Payment in connection with a transaction expressly permitted pursuant to this Agreement, or (f) any amendment to this Section 10.3 or Section 8.5 hereof. In addition, Section 10.12 hereof may not be amended without the prior written consent of any Designating Bank, as defined in Section 10.12 hereof, affected thereby. Notice of amendments or consents ratified by the Banks hereunder shall immediately be forwarded by Borrower to all Banks. Each Bank or other holder of a Note shall be bound by any amendment, waiver or consent obtained as authorized by this Section, regardless of its failure to agree thereto.

  • Authorizations and Approvals Each Borrower shall promptly obtain, from time to time at its own expense, all such Governmental Approvals as may be required to enable such Borrower to comply with its obligations, under the Loan Documents and its Constituent Documents, and to conduct its business in the customary fashion.

  • Filings and Approvals Cooperate with the other in the preparation and filing, as soon as practicable, of (A) the Applications, (B) the Proxy Statement, (C) all other documents necessary to obtain any other approvals, consents, waivers and authorizations required to effect the completion of the Merger and the other transactions contemplated by this Agreement, and (D) all other documents contemplated by this Agreement;

  • Consent and Approvals Except as otherwise expressly provided in this Agreement, all consents or approvals required under the terms of this Agreement must be in writing and will not be unreasonably withheld or delayed.

  • Supplements, Amendments and Waivers This Agreement may be supplemented or amended only by a subsequent writing signed by each of the parties hereto (or their successors or permitted assigns), and any provision hereof may be waived only by a written instrument signed by the party charged therewith.

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