Process Modifications Sample Clauses
The Process Modifications clause defines the procedures and conditions under which changes to established processes or workflows may be made during the course of an agreement. Typically, this clause outlines who has the authority to propose or approve modifications, the required notice period, and any documentation or approval steps necessary before changes take effect. By establishing a clear framework for altering processes, the clause helps ensure that all parties are informed and in agreement about operational changes, thereby reducing confusion and minimizing disputes related to unexpected or unilateral modifications.
POPULAR SAMPLE Copied 1 times
Process Modifications. BioGeneriX will not modify any process or procedure used in the manufacture of a Product without obtaining the prior consent of Neose, which shall not be unreasonably withheld or delayed.
Process Modifications. Spark shall not be entitled to modify the process employed in the manufacture of the Product as set out in the DMF without first having consulted with Genable and then only with Genable’s prior written agreement and also in compliance with all applicable regulatory requirements in the United States and EU with respect to such modification.
Process Modifications. JBI may make Process Modifications to any 214 Immunotherapeutic or Permitted Derivative Immunotherapeutic independently of Aduro, and without Aduro’s consent. Any Process Modifications developed independently by Aduro shall constitute Aduro Intellectual Property and will be disclosed to JBI by Aduro.
Process Modifications. JBI may make Process Modifications to GVAX Licensed Therapeutic independently of Aduro, and without Aduro’s consent. Any Process Modifications developed independently by Aduro shall constitute Aduro Intellectual Property and will be disclosed to JBI by Aduro.
Process Modifications. 14.1 Purepac shall not make any modifications to any of its manufacturing operations relating to the Product or to raw material sources that would require a modification to any Regulatory Document without the prior written consent of Alpharma which shall not be unreasonably withheld. Once a Regulatory Document has been filed with a Governmental Agency, Purepac agrees to take no action that would invalidate or otherwise jeopardize the information included in such Regulatory Document.
14.2 The Parties have agreed to a document (attached hereto as Appendix 6) which describes the necessary change control procedure and change control specifications to be followed, which cannot be changed unless both parties agree in writing.