Common use of Manufacture; Quality Clause in Contracts

Manufacture; Quality. Subject to Article VII, Orphan Medical agrees to manufacture Celltech's requirements for Product as necessary to satisfy Celltech's forecasts and purchase orders submitted by Celltech pursuant to this Agreement. Products delivered to Celltech pursuant to this Agreement shall be manufactured in accordance with the Quality Agreement negotiated and finalized between Orphan Medical and Celltech prior to Marketing Authorization approval in any country in the Territory, such agreement to be substantially in the form attached hereto as Appendix E. Such Quality Agreement shall be agreed upon by the parties no later than twelve (12) months after the Effective Date. The Quality Agreement shall include the obligations and pharmaceutical responsibilities of Orphan Medical, Orphan Medical's sub-contractors and Celltech relating to the quality assurance requirements for the manufacture and supply of the Product, all in accordance with cGMP and applicable regulatory requirements.

Manufacture; Quality. Subject to Article VII, Orphan Medical agrees to manufacture Celltech's ’s requirements for Product as necessary to satisfy Celltech's ’s forecasts and purchase orders submitted by Celltech pursuant to this Agreement. Products delivered to Celltech pursuant to this Agreement shall be manufactured in accordance with the Quality Agreement negotiated and finalized between Orphan Medical and Celltech prior to Marketing Authorization approval in any country in the Territory, such agreement to be substantially in the form attached hereto as Appendix E. Such Quality Agreement shall be agreed upon by the parties no later than twelve (12) months after the Effective Date. The Quality Agreement shall include the obligations and pharmaceutical responsibilities of Orphan Medical, Orphan Medical's ’s sub-contractors and Celltech relating to the quality assurance requirements for the manufacture and supply of the Product, all in accordance with cGMP and applicable regulatory requirements.