Approvable Letter Sample Clauses

Approvable Letter. AstraZeneca shall have the right, in its sole discretion and for any reason, to terminate this Agreement in its entirety, upon ninety (90) days' prior written notice, at any time during the [****] period following receipt of an Approvable Letter from the FDA if the Approvable Letter specifies additional ------- [****] indicates that certain confidential information contained in this document has been omitted pursuant to a request for confidential treatment and filed separately with the Securities and Exchange Commission. information or materials required, or specified conditions, that are reasonably likely to require, in order to obtain U.S. NDA Approval, either (i) more than twenty-four (24) months from receipt of such Approvable Letter to submit such additional information or materials to meet such condition, or (ii) reasonable out-of-pocket costs paid to Third Parties (whether or not AstraZeneca were to actually engage Third Parties for such activities or perform them internally) of more than [****] by AstraZeneca for items or activities not included in the Initial Development Plan, unless AGIX agrees to pay any amounts in excess of such [****].
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Related to Approvable Letter

  • Assignment Entire Agreement Amendment This Agreement may be assigned only by Employer, and is freely assignable by Employer. This Agreement constitutes the entire agreement between the parties concerning the subject matter of this Agreement and supersedes all prior understandings, communications and agreements concerning such subject matter; provided that, to the extent there is any conflict between this Agreement and any stock option grant agreement or plan, the provisions of this Agreement shall control. Neither this Agreement, nor any of its terms, can be changed, added to, waived or supplemented except in a written document signed by Executive and Employer, except that Employer may adopt or change any vacation, benefit, rules or other policy generally applicable to employees or a group or class of employees in its discretion.

  • Approval of Leases, Contracts, Etc In fulfilling its duties to Owner, Manager may and hereby is authorized to enter into any leases, contracts or agreements on behalf of Owner in the ordinary course of the management, operation, maintenance and leasing of the Property.

  • Amendment of Material Documents No Loan Party will, nor will it permit any Subsidiary to, amend, modify or waive any of its rights under (a) any agreement relating to any Subordinated Indebtedness, or (b) its charter, articles or certificate of organization or incorporation and bylaws or operating, management or partnership agreement, or other organizational or governing documents, to the extent any such amendment, modification or waiver would be adverse to the Lenders.

  • APPROVAL OF PLANS AND SPECIFICATIONS The Plans and Specifications will conform to the requirements and conditions set out by applicable law or any effective restrictive covenant, and to all governmental authorities which exercise jurisdiction over the Leased Premises or the construction thereon.

  • Consent and Agreement An original of a Consent and Agreement duly executed by such Subsidiary, pursuant to which such Subsidiary consents and agrees to become a “Credit Party” hereunder and to be bound by the terms and conditions of this Agreement and all other Loan Documents;

  • Complete Agreement; Amendment The parties acknowledge that this Agreement is the complete and exclusive statement of agreement respecting the subject matter hereto and supersedes all proposals (oral or written), understandings, representations, conditions, and other communications between the parties relating hereto, including the Former Agreement. This Agreement may be amended only by a subsequent writing that specifically refers to this Agreement and is signed by both parties, and no other act, document, purchase order, usage, or custom shall be deemed to amend this Agreement.

  • Assignment of Management Agreement As additional collateral security for the Loan, Borrower conditionally transfers, sets over, and assigns to Lender all of Borrower’s right, title and interest in and to the Management Agreement and all extensions and renewals. This transfer and assignment will automatically become a present, unconditional assignment, at Lender’s option, upon a default by Borrower under the Note, the Loan Agreement, the Security Instrument or any of the other Loan Documents (each, an “Event of Default”), and the failure of Borrower to cure such Event of Default within any applicable grace period.

  • Amendment, Etc. of Material Contracts Cancel or terminate any Material Contract or consent to or accept any cancellation or termination thereof, amend or otherwise modify any Material Contract or give any consent, waiver or approval thereunder, waive any default under or breach of any Material Contract, agree in any manner to any other amendment, modification or change of any term or condition of any Material Contract or take any other action in connection with any Material Contract that would impair in any material respect the value of the interest or rights of any Loan Party thereunder or that would impair or otherwise adversely affect in any material respect the interest or rights, if any, of any Agent or any Lender Party, or permit any of its Subsidiaries to do any of the foregoing, in each case in a manner that could reasonably be expected to have a Material Adverse Effect, in each case taking into account the effect of any agreements that supplement or serve to substitute for, in whole or in part, such Material Contract.

  • Estoppel Certificate or Subordination Agreement Tenant fails to execute any document required from Tenant under Sections 23 or 27 within 5 days after a second notice requesting such document.

  • Complete Agreement; Amendments This Amendment and the Loan Documents represent the entire agreement about this subject matter and supersede prior negotiations or agreements with respect to such subject matter. All prior agreements, understandings, representations, warranties, and negotiations between the parties about the subject matter of this Amendment and the Loan Documents merge into this Amendment and the Loan Documents.

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