Manufacturing Processes. 8.1 Horizon shall use all of its contractual rights to cause the Third-Party Manufacturer at all times to operate in accordance with the criteria defined in the Technical Agreement and in compliance with the Registrations and cGMP and all other relevant regulations and legislation. Horizon shall regularly audit the Third-Party Manufacturer and endeavour to ensure that they receive regular inspections by the relevant Medicines Inspectorate to ensure that the Manufacturing processes are always in conformity with such requirements. 8.2 The parties shall enter into the Technical Agreement as soon as practicable after the Commencement Date but no later than ninety (90) days after the Commencement Date. 8.3 Any delivery of the Products to Mundipharma or its designee must be first analyzed by the Third-Party Tester or Horizon and released by the Third-Party Tester or Horizon’s Qualified Person (the “QP”), or a person acting on Horizon’s authority in the capacity of person responsible for quality assurance. This QP shall draw up a written report certifying the conformity of the delivery to the conditions specified in the Technical Agreement.
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Sources: Manufacturing Agreement (Horizon Pharma, Inc.), Manufacturing Agreement (Horizon Pharma, Inc.)