CGMP Negotiation and Execution Clause Samples

The CGMP Negotiation and Execution clause establishes the requirement for both parties to negotiate and finalize a Current Good Manufacturing Practice (CGMP) agreement before commencing manufacturing activities. This clause typically outlines the process for agreeing on specific CGMP standards, responsibilities, and documentation, ensuring that both parties are aligned on regulatory compliance and quality expectations. Its core function is to ensure that manufacturing operations meet regulatory standards and to prevent misunderstandings or non-compliance issues by requiring clear, mutual agreement on CGMP obligations before work begins.
CGMP Negotiation and Execution. If the Director agrees to authorize the commencement of a portion of Construction under a CGMP Submittal, the DESIGN BUILD CONTRACTOR and Director shall negotiate and enter into a CGMP Amendment. A CGMP Amendment at a minimum shall incorporate and definitively address all of the items identified in Exhibit “F” and shall contain any other commercial terms and conditions specific to the Advanced Package (but shall not alter the terms and conditions of this Contract). Advanced Packages may be structured in a manner that provides for the commencement of the related Construction at any time determined by the Parties.
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Related to CGMP Negotiation and Execution

  • Authorization and Execution The execution, delivery and performance of this Agreement has been duly authorized by all necessary action on the part of such Purchaser, and, assuming due authorization, execution and delivery by the other parties hereto, this Agreement is a legal, valid and binding obligation of such Purchaser, enforceable against such Purchaser in accordance with its terms, except as enforcement thereof may be limited by bankruptcy, insolvency, reorganization, moratorium or other similar laws relating to or affecting creditors’ rights generally or by general equitable principles.

  • Negotiation of Agreement Each of the parties acknowledges that it has been represented by independent counsel of its choice throughout all negotiations that have preceded the execution of this Agreement and that it has executed the same with consent and upon the advice of said independent counsel. Each party and its counsel cooperated in the drafting and preparation of this Agreement and the documents referred to herein, and any and all drafts relating thereto shall be deemed the work product of the parties and may not be construed against any party by reason of its preparation. Accordingly, any rule of law or any legal decision that would require interpretation of any ambiguities in this Agreement against the party that drafted it is of no application and is hereby expressly waived. The provisions of this Agreement shall be interpreted in a reasonable manner to effect the intentions of the parties and this Agreement.

  • Execution of Agreement The HSP represents and warrants that: (a) it has the full power and authority to enter into this Agreement; and (b) it has taken all necessary actions to authorize the execution of this Agreement.

  • Preparation of Agreement The parties acknowledge that they have sought and obtained whatever competent advice and counsel as was necessary for them to form a full and complete understanding of all rights and obligations herein and that the preparation of this Agreement has been their joint effort. The language agreed to herein expresses their mutual intent and the resulting document shall not, solely as a matter of judicial construction, be construed more severely against one of the parties than the other.

  • Execution and Effect of Agreement Buyer has the requisite corporate power and authority to enter into this Agreement and to perform its obligations hereunder, and the execution and delivery of this Agreement and the consummation of the transactions contemplated hereby and the performance of Buyer’s obligations hereunder have been duly authorized by all necessary corporate action on the part of Buyer. This Agreement has been duly executed and delivered by Buyer and constitutes the legal, valid and binding obligation of Buyer, enforceable against it in accordance with its terms, subject to the Enforceability Exceptions.