Common use of API Yield Clause in Contracts

API Yield. 2.11.1 Patheon shall promptly (and in any event no later than *** Business Days after Santarus' request) provide an inventory status report to Santarus from time to time as reasonably requested by Santarus. In addition, Patheon shall monitor on a monthly basis the inventory of Bulk API held by Patheon and Patheon shall provide Santarus with a monthly inventory report (within *** Business Days following the last day of the applicable month) of the Bulk API held by Patheon, which shall contain the following information for such month: QUANTITY RECEIVED: The total quantity of Bulk API that complies with the Specifications and is received at the Facility during the applicable period. QUANTITY DISPENSED: The total quantity of Bulk API dispensed at the Facility during the applicable period. The Quantity Dispensed is calculated by adding the Quantity Received to the inventory of Bulk API that complies with the Specifications and is held at the beginning of the applicable period, less the inventory of Bulk API that complies with the Specifications and is held at the end of such period. The Quantity Dispensed shall only include Bulk API received and dispensed in connection with commercial manufacturing of Finished Product and, for certainty, shall not include any Bulk API received or dispensed in connection with technical transfer activities or development activities during the applicable period, including, without limitation, any regulatory, stability, validation or test batches manufactured during the applicable period.

API Yield. 2.11.1 Patheon Manufacturer shall promptly (and in any event no later than *** two (2) Business Days after Santarus' request) provide an inventory status report to Santarus from time to time as reasonably requested by Santarus. In addition, Patheon Manufacturer shall monitor on a monthly basis the inventory of Bulk API held by Patheon Manufacturer and Patheon Manufacturer shall provide Santarus with a monthly inventory report (within *** five (5) Business Days following the last day of the applicable month) of the Bulk API held by PatheonManufacturer, which shall contain the following information for such month: QUANTITY RECEIVED: The total quantity of Bulk API that complies with the Specifications and is received at the Facility during the applicable period. QUANTITY DISPENSED: The total quantity of Bulk API dispensed at the Facility during the applicable period. The Quantity Dispensed is calculated by adding the Quantity Received to the inventory of Bulk API that complies with the Specifications and is held at the beginning of the applicable period, less the inventory of Bulk API that complies with the Specifications and is held at the end of such period. The Quantity Dispensed shall only include Bulk API received and dispensed in connection with commercial manufacturing of Finished Product and, for certainty, shall not include any Bulk API received or dispensed in connection with technical transfer activities or development activities during the applicable period, including, without limitation, any regulatory, stability, validation or test batches manufactured during the applicable period.

API Yield. 2.11.1 Patheon Manufacturer shall promptly (and in any event no later than *** two (2) Business Days after Santarus' ’ request) provide an inventory status report to Santarus from time to time as reasonably requested by Santarus. In addition, Patheon Manufacturer shall monitor on a monthly basis the inventory of Bulk API held by Patheon Manufacturer and Patheon Manufacturer shall provide Santarus with a monthly inventory report (within *** five (5) Business Days following the last day of the applicable month) of the Bulk API held by PatheonManufacturer, which shall contain the following information for such month: QUANTITY RECEIVED: The total quantity of Bulk API that complies with the Specifications and is received at the Facility during the applicable period. QUANTITY DISPENSED: The total quantity of Bulk API dispensed at the Facility during the applicable period. The Quantity Dispensed is calculated by adding the Quantity Received to the inventory of Bulk API that complies with the Specifications and is held at the beginning of the applicable period, less the inventory of Bulk API that complies with the Specifications and is held at the end of such period. The Quantity Dispensed shall only include Bulk API received and dispensed in connection with commercial manufacturing of Finished Product and, for certainty, shall not include any Bulk API received or dispensed in connection with technical transfer activities or development activities during the applicable period, including, without limitation, any regulatory, stability, validation or test batches manufactured during the applicable period. QUANTITY CONVERTED: The total amount of Bulk API contained in the Finished Products produced with the Quantity Dispensed, delivered by Manufacturer, and not rejected or returned in accordance with Section 3.5 or recalled under Article 5 as a result of a failure by Manufacturer to manufacture Finished Product that conforms to the Manufacturer Manufacturing Responsibilities. 2.11.2 In addition, Manufacturer shall reconcile the inventory of Bulk API held by Manufacturer on a [***] basis and shall provide a report to Santarus concerning such reconciliation within ten (10) days following the end of the applicable [***]. Within [***] days of the end of each six (6) month period after the Commencement of Commercial Manufacturing, Manufacturer shall calculate the “ACTUAL SIX-MONTH YIELD” or “ASY” for the Finished Product during the six-month period, which ASY is the percentage of the Quantity Dispensed that was converted to Finished Products and is calculated as follows: Quantity Converted during the six-month period Quantity Dispensed during the six-month period 2.11.3 After Manufacturer has produced a minimum of [***] batches of Finished Product and has produced batches for at least [***] months pursuant to this Agreement, the Parties will mutually agree on the target yield (each, a “TARGET YIELD”). Thereafter, Manufacturer shall strive to maintain Actual Six-Month Yield levels for each Finished Product above the applicable Target Yield. If the Actual Six-Month Yield falls below the respective Target Yield in any six month period, then Manufacturer shall reimburse Santarus for the cost of the shortfall based on the following calculation: [***] *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 2.11.4 Manufacturer shall notify Santarus in writing in the event that an amount in excess of [***] kilograms of Bulk API is damaged, lost or otherwise rendered unusable (including to the extent contained in any non-conforming Finished Product) at any one time (a “Significant API Loss”) as soon as practicable following such incident. In addition, and notwithstanding any provision in this Section 2.11 to the contrary, Manufacturer shall reimburse Santarus for such Bulk API within [***] days after discovery of the Significant API Loss. 2.11.5 For the purposes of clarity, any Bulk API damaged, lost or otherwise rendered unusable in connection with the Significant API Loss shall be included in the calculation of the Quantity Dispensed and any amount paid by Manufacturer in accordance with subsection 2.11.4 shall be credited against the amount, if any, to be paid by Manufacturer to Santarus pursuant to subsection 2.11.3.