Common use of Technical Transfer Clause in Contracts

Technical Transfer. Horizon shall provide to sanofi-aventis US or its designated Affiliate without any cost or expense to sanofi-aventis US and such Affiliate, all analytical, manufacturing, technical and other methods, processes, records and Know-How in Horizon’s control and necessary or useful to enable sanofi-aventis US or such Affiliate to produce the Product in conformance with the Product Specifications and current Good Manufacturing Practice, including, but not limited to, any manufacturing instructions, specifications (including, without limitation, Product Specifications, starting material specifications, and specifications for the Product or any intermediate version of the Product), development reports, production summaries, regulatory filings, validation reports, quality control and quality assurance documents, analytical methods and validation reports and any production or development batch records (the “Technical Transfer”). Should sanofi-aventis US or its designated Affiliate reasonably require any analytical, manufacturing, technical and other methods, processes, records and Know-How to perform its obligations under this Agreement, Horizon is responsible for obtaining such information at its own cost and providing it to sanofi-aventis US or such Affiliate as promptly as reasonably practicable. A preliminary manufacturing process description is attached hereto as Exhibit 1. The Parties acknowledge that a final manufacturing process has not yet been developed. Accordingly, the Parties agree that, to the extent that the definitive manufacturing process or final Product Specifications have an adverse financial impact on the projected costs set forth in Section 4 hereto, including, without limitation, any supply price, each Party agrees to negotiate revisions to such costs in good faith. To the extent that, despite good faith efforts, the Parties cannot reach agreement on modified costs, either Party may terminate this agreement.