PROCEDURES REGARDING CHANGES TO MANUFACTURING PROCESS Clause Samples

PROCEDURES REGARDING CHANGES TO MANUFACTURING PROCESS. (a) At its initial meeting, the MWG will consider and agree upon the guidelines to be used to determine the approval process to be applied to any material change in Manufacturing materials, equipment, processes, procedures, or to the API Specifications proposed by ISIS. ISIS will prepare and submit the guidelines to the MWG for consideration, using the following 3 categories and providing examples of the types of material changes that will be included in each category: (i) changes in production of API that may affect the filing of an application for Marketing Approval or require prior Regulatory Approval and will thus require LILLY's approval prior to implementation; (ii) changes that will require ISIS to notify LILLY prior to implementation, but which do not require LILLY's approval; and (iii) changes that do not require ISIS to notify LILLY prior to implementation. (b) If ISIS proposes to make a material change described in subsection (a)(i), ISIS will notify the MWG and provide information to the MWG regarding such change at a level sufficient to allow the MWG members to evaluate the impact of such change on the Manufacturing Process, and to form a basis for LILLY to determine whether or not to approve such material change. If there are any additional questions regarding notification and approval that arise during the term of this Agreement, ISIS will submit the questions to the MWG or, if an immediate response is required, will contact LILLY's Quality Assurance function to determine the level of review/notification that may be required by the proposed change. The parties will obtain the prior Regulatory Approval and any other required approvals, if such approval is required, before any such material change is implemented.