Common use of Active Ingredient Clause in Contracts

Active Ingredient. Sanofi-aventis shall, at its cost, procure the Active Ingredient(s) and applicable reference standards in quantities sufficient to meet Horizon’s requirements for Product as further set forth herein, provided such purchases of Horizon API shall be made under Horizon’s contracted conditions with Horizon API suppliers. Horizon shall be responsible for necessary supplier audits and cost of any audit of Horizon API suppliers, the frequency of such audits to be based upon site and regulatory requirements. Horizon shall make every effort to allow sanofi-aventis qualified personnel to participate in such Horizon API audits. In the event a sanofi-aventis qualified person is prohibited from participating in such an audit, sanofi-aventis will provide audit requirements and templates that can be substituted such that sanofi-aventis can meet its vendor qualification obligation. Horizon agrees to use commercially reasonable efforts to conduct an audit of the Horizon API suppliers, at sanofi-aventis’ request if Horizon has the right to do so under the applicable contracted conditions with such Horizon API suppliers; provided, that sanofi-aventis shall be responsible for all costs and expenses of Horizon in connection therewith. Horizon shall provide to sanofi-aventis a copy of any reports of any Horizon API supplier deficiencies discovered as a result of an audit or otherwise, and shall provide a written action plan for the prompt resolution of any such deficiencies and / or a report of the full resolution of the same. Notwithstanding anything contained herein to the contrary, sanofi-aventis shall have no liability in the event Product is delivered late by sanofi-aventis or in insufficient quantities or fails to comply with Specifications solely because and to the extent such Horizon API was delivered late or in insufficient quantities to sanofi-aventis or did not comply with the specifications for such Horizon API, respectively, in each case for reasons outside the reasonable control of sanofi-aventis. Sanofi-aventis shall be responsible for necessary supplier audits and cost of any audit of sanofi-aventis API suppliers, the frequency of such audits to be based upon site and regulatory requirements. Sanofi-aventis shall make every effort to allow Horizon qualified personnel to participate in such sanofi-aventis API audits. In the event a Horizon qualified person is prohibited from participating in such an audit, Horizon will provide audit requirements and templates that can be substituted such that Horizon can meet its vendor qualification obligation. Sanofi-aventis agrees to use commercially reasonable efforts to conduct an audit of the sanofi-aventis API suppliers, at Horizon’s request if sanofi-aventis has the right to do so under the applicable contracted conditions with such sanofi-aventis API suppliers; provided, that Horizon shall be responsible for all costs and expenses of sanofi-aventis in connection therewith. Sanofi-aventis shall provide to Horizon a copy of any reports of any sanofi-aventis API supplier deficiencies discovered as a result of an audit or otherwise, and shall provide a written action plan for the prompt resolution of any such deficiencies and / or a report of the full resolution of the same.

Active Ingredient. Sanofi-aventis shall, at its cost, procure the Active Ingredient(s) and applicable reference standards in quantities sufficient to meet Horizon’s requirements for Product as further set forth herein, provided such purchases of Horizon API shall be made under Horizon’s contracted conditions with Horizon API suppliers. Horizon shall be responsible for necessary supplier audits and cost of any audit of Horizon API suppliers, the frequency of such audits to be based upon site and regulatory requirements. Horizon shall make every effort to allow sanofi-aventis qualified personnel to participate in such Horizon API audits. In the event a sanofi-aventis qualified person is prohibited from participating in such an audit, sanofi-aventis will provide audit requirements and templates that can be substituted such that sanofi-aventis can meet its vendor qualification obligation. Horizon agrees to use commercially reasonable efforts to conduct an audit of the Horizon API suppliers, at sanofi-aventis’ request if Horizon has the right to do so under the applicable contracted conditions with such Horizon API suppliers; provided, that sanofi-aventis shall be responsible for all costs and expenses of Horizon in connection therewith. Horizon shall provide to sanofi-aventis a copy of any reports of any Horizon API supplier deficiencies discovered as a result of an audit or otherwise, and shall provide a written action plan for the prompt resolution of any such deficiencies and / or a report of the full resolution of the same. Notwithstanding anything contained herein to the contrary, sanofi-aventis shall have no liability in the event Product is delivered late by sanofi-aventis or in insufficient quantities or fails to comply with Specifications solely because and to the extent such Horizon API was delivered late or in insufficient quantities to sanofi-aventis or did not comply with the specifications for such Horizon API, respectively, in each case for reasons outside the reasonable control of sanofi-aventis. Sanofi-aventis shall be responsible for necessary supplier audits and cost of any audit of sanofi-aventis API suppliers, the frequency of such audits to be based upon site and regulatory requirements. Sanofi-aventis shall make every effort to allow Horizon qualified personnel to participate in such sanofi-aventis API audits. In the event a Horizon qualified person is prohibited from participating in such an audit, Horizon will provide audit requirements and templates that can be substituted such that Horizon can meet its vendor qualification obligation. Sanofi-aventis agrees to use commercially reasonable efforts to conduct an audit of the sanofi-aventis API suppliers, at Horizon’s request if sanofi-aventis has the right to do so under the applicable contracted conditions with such sanofi-aventis API suppliers; provided, that Horizon shall be responsible for all costs and expenses of sanofi-aventis in connection therewith. Sanofi-aventis shall provide to Horizon a copy of any reports of any ***Confidential Treatment Requested MANUFACTURING AND SUPPLY AGREEMENT PAGE 10 sanofi-aventis API supplier deficiencies discovered as a result of an audit or otherwise, and shall provide a written action plan for the prompt resolution of any such deficiencies and / or a report of the full resolution of the same.