Regulatory and Quality Responsibilities Clause Samples

Regulatory and Quality Responsibilities. 6.1 Genzyme shall obtain and maintain any and all regulatory and governmental permits, licenses and approvals that are necessary for Genzyme to Manufacture the Product for Semnur or its Affiliates in accordance with the terms of this Supply Agreement and Applicable Law. The Parties or their Affiliates shall enter into a Quality Agreement for the manufacture of the Product, which shall be agreed by the Parties within one-hundred twenty (120) days after the Effective Date. 6.2 Changes or Modifications in Manufacturing Activities. Genzyme shall promptly make and implement such changes as are required by Applicable Law (“Required Changes”), provided that, prior to implementation, all such Required Changes shall utilize Genzyme’s change control process. Genzyme shall inform Semnur of any estimated effect on Supply Price and other issues regarding such implementation of Required Changes if relevant. In addition, Semnur shall have the right to request changes in or modifications to the Specifications (“Voluntary Changes”). Genzyme shall review such requests for Voluntary Changes and advise Semnur if such changes are feasible. Voluntary changes require the mutual agreement of the parties. All such Voluntary Changes shall be documented in writing and shall be signed by an authorized representative of Semnur and Genzyme. Such Voluntary Changes shall utilize Genzyme’s change control process. If such Voluntary Changes result in a material change in Genzyme’s manufacturing costs or lead times or capacity, prior to implementation the Parties shall agree upon an appropriate adjustment to the Supply Price solely to reflect the actual increase in Genzyme’s manufacturing costs and compensation for Genzyme’s one-time costs necessary for such Voluntary Changes or in the delivery schedules, as the case may be, for Product(s) to be provided by Genzyme hereunder.
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Regulatory and Quality Responsibilities 
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