DMF/Amendment Sample Clauses

DMF/Amendment. Upon Magenta’s reasonable request and order, Bachem will compile a DMF for the Product in cooperation and mutual agreement with Magenta. Bachem hereby grants to Magenta, at no additional cost, reference rights to the DMFs, which are necessary to support Magenta’s regulatory submissions with respect to the Product. Bachem shall provide reasonable advance written notice to Magenta prior to amending any Bachem DMF that is referenced in a filed IND of Magenta or in a proposed IND filing of Magenta. Bachem will, at Magenta’s expense, provide reasonable assistance as necessary so that the FDA (and/or equivalent foreign regulatory authority) can reference the relevant DMF. Bachem shall not permit the FDA or any other regulatory authority to reference its DMF in order to permit a Third Party to develop, manufacture or commercialize CXCR2 Ligand or any products that incorporate CXCR2 Ligand or compete with CXCR2 Ligand. In the event that the Parties agree that Bachem will not file a DMF in connection with a Project Plan, Bachem shall instead fully cooperate with Magenta, and provide a quote (similar to the compiling of a DMF) to provide all information, data, and rights of reference reasonably required by Magenta in connection with its regulatory and governmental filings related to Product.
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Related to DMF/Amendment

  • Waiver; Amendment Except as expressly provided in this Agreement, no amendment or waiver of this Agreement shall be binding unless executed in writing by the party to be bound thereby. No waiver of any provision of this Agreement shall constitute a waiver of any other provision nor shall any waiver of any provision of this Agreement constitute a continuing waiver unless otherwise expressly provided.

  • Certificate of Amendment A successor Owner Trustee appointed under this Agreement will promptly file a certificate of amendment to the Certificate of Trust with the Secretary of State of the State of Delaware identifying the name and principal place of business of the successor Owner Trustee in the State of Delaware. The successor Owner Trustee will promptly deliver a file-stamped copy of the certificate of amendment to the Administrator.

  • Modification, Amendment and Waiver The authority of the Trustees hereunder to authorize the Trust to enter into contracts or other agreements or arrangements shall include the authority of the Trustees to modify, amend, waive any provision of supplement, assign all or a portion of, novate, or terminate such contracts, agreements or arrangements. The enumeration of any specific contracts in this Section 5.12 shall in no way be deemed to limit the power and authority of the Trustees as otherwise set forth in this Declaration of Trust to authorize the Fund to engage, contract with or make payments to such Persons as the Trustees may deem desirable for the transaction of the business of the Fund.

  • Effective Date of Amendment This Amendment shall be deemed effective as of the date first written above, as if executed on such date.

  • Notice of Amendment ‌ 16 Except when a longer period is requested by applicable law, North Sound BH-ASO may amend 17 this Agreement upon 30 days prior written notice to Provider. If Provider does not deliver to 18 North Sound BH-ASO a written notice of rejection of the amendment within that 30-day 19 period, the amendment shall be deemed accepted by and shall be binding upon Provider.

  • Scope of Amendment This Amendment shall amend, modify and revise the Agreement only to the extent set forth expressly in this Amendment and, except to the extent expressly set forth in this Amendment, the terms and conditions of the Agreement shall remain in full force and effect after the Amendment Effective Date. For the avoidance of any doubt, nothing in this Amendment shall be deemed to amend or extend the term of the Amended Agreement, or to affect the right of a Party to exercise any right of termination it may have under the Amended Agreement.

  • Modification; Amendment This Agreement may not be modified or amended except pursuant to an instrument in writing signed by the Company and each of the Purchasers.

  • Execution of Amendment Submission of this Amendment by Landlord is not an offer to enter into this Amendment but rather is a solicitation for such an offer by Tenant. Landlord shall not be bound by this Amendment until Landlord has executed and delivered the same to Tenant.

  • Articles of Amendment In connection with the First Closing, the Company shall file the Articles of Amendment in the Commonwealth of Virginia, and such Articles of Amendment shall continue to be in full force and effect as of the First Closing Date and the Second Closing Date.

  • Agreement Amendment If either party hereto requests to amend this agreement, it shall notify the other party in writing, and the other party shall respond within one week. All amendments of this agreement must be made in writing by both parties, and such amendments shall be deemed as inseverable parts of this agreement.

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