Quality Technical Agreement. Within sixty (60) days after the Effective Date, the Parties shall enter into a Quality Technical Agreement outlining responsibilities and key contacts for API quality and compliance related issues. Helsinn will provide Indevus with certain production and control information for review prior to release as specified in the Quality Technical Agreement. The Quality Technical Agreement will also address, without limitation, annual product reviews, returned goods, regulatory audits, compliance with Current Good Manufacturing Practices, and such other quality related concerns deemed appropriate. The final agreed Quality Technical Agreement will be attached to this Agreement as Exhibit 1.22 and deemed a part of this Agreement. In the event that the Quality Technical Agreement contains material provisions that substantially differ from applicable comparable Regulatory Standards, the Regulatory Standards shall control.
Appears in 2 contracts
Sources: Api Supply Agreement, Api Supply Agreement (Indevus Pharmaceuticals Inc)