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. After Merrimack has supplied at least [**] batches of Product to Actavis for each batch size, the Parties shall mutually agree upon an acceptable yield loss for the API used in the manufacture of the Product at that batch size, on either a per batch or an annual basis. After Merrimack has supplied at least [**] batches of Product, that yield shall be reevaluated and, if appropriate, adjusted by the Parties to reflect long term API yield for the manufacture of the Bulk Product. If Merrimack thereafter exceeds that agreed upon yield loss, a credit shall be given to Actavis towards the purchase of future Product in an amount equal to Actavis’ direct material cost for the lost API beyond the agreed upon yield loss or, if Merrimack is no longer manufacturing that Product, a refund of such amount. Actavis shall document its cost of API supplied to Merrimack in connection with any claim for loss.
API Yield. The Parties shall evaluate and mutually determine an acceptable target yield, for each calendar year during the Term, after the Manufacture of the first [*] initial Batches of Cartridges Manufactured hereunder, taking into account, fixed and flexible losses, including samples, pre-flush (forerun) volume, overfill and second in-line filter; provided, however, [*] shall, as a buffer, be deducted therefrom (in percent, the “Target Yield”). Until the Target Yield is established, Radius shall be responsible for the costs and/or expenses with respect to all of such API used in excess of an Actual Yield of[*], in the aggregate, with respect to the first [*] initial Batches of Cartridges Manufactured hereunder, and any other costs and/or expenses incurred by Radius in respect thereof, and Xxxxxx shall be responsible to compensate Radius, at the API Value, for an Actual Yield less than[*], in the aggregate, in respect of such first [*] initial Batches of Cartridges Manufactured hereunder as mentioned above, and costs and/or expenses incurred in respect thereof. Once established, the Target Yield shall be reviewed and re-calculated[*], at the business review meetings of Radius and Xxxxxx, and an update thereof may be agreed by Parties from time to time through good faith negotiations, taking into account the previous year’s performance, process enhancements, improvements and changes, cGMP, SOPs and all other relevant circumstances; provided, however, that (i) the Target Yield shall never be less than[*], in the[*]; (ii) the Target Yield shall not be reviewed or re-calculated, as the case may be, but instead not apply at all, if the Manufacture of the Cartridges has been halted or interrupted for a period of [*] or more, or if, in any calendar year, less than one (1) commercial Batch has been Manufactured; (iii) Xxxxxx Pharma’s previous performance shall not be determinative and shall not by itself set any precedence for such review, good faith negotiations, and agreement. The Parties shall, after the end of each calendar year, mutually determine and agree on the total actual amount of API used in that calendar year and on the Actual Yield. To the extent that the Actual Yield is equal to, or greater than, the Target Yield, all use of API, and all costs and/or expenses incurred in respect thereof, shall be borne by Radius. If the Actual Yield should be less than the Target Yield, in the[*], Xxxxxx shall reimburse Radius for such excess use of API, multiplied by the AP...
API Yield. Zegerid® Trade Product Target API Yield is [***]%
API Yield. A. CoreRx will give Client a quarterly inventory report of the API held by CoreRx (“Inventory Report”) within [***] business days of the end of the most recent [***]-month period in a Contract Year which contains the following information for such period: (a) quantity of API conforming to Specifications that is received at the Facility (“Quantity Received”), (b) quantity of API dispensed in Manufacturing Product at the Facility calculated by adding the Quantity Received to the inventory of API that complies with the Specifications and is held by CoreRx at the beginning of the applicable period, less the inventory of API that complies with the Specifications and is held by CoreRx at the end of the period (“Quantity Dispensed”), and (c) the total amount of API contained in the Product manufactured with the Quantity Dispensed delivered by CoreRx and not rejected, recalled or returned due to CoreRx Cause as defined below (“Quantity Converted”).
B. Within [***] days after the end of each Contract Year, CoreRx will prepare an annual reconciliation of API that sets out the “Actual Annual Yield” or “AAY” for the Product at the Facility during the Contract Year. AAY is the percentage of the Quantity Dispensed that was converted to Product and is calculated as follows: Quantity Converted in Contract Year/Quantity Dispensed during Contract Year * 100. The parties agree that the target AAY will be determined as follows:
i. Initial Target Yield - will be the actual yield of the initial pre-validation and validation batches of Product that is Processed for Client and calculated as follows: Quantity Converted in the initial pre-validation and validation batches /Quantity Dispensed in the initial pre-validation and validation batches * 100 (the “Initial Target Yield”). The Initial Target Yield will be in effect until there is enough campaign experience to calculate an Adjusted Target Yield as defined below.
ii. Adjusted Target Yield - will be the actual average yield of the initial ten commercial batches of Product that is Processed for Client and calculated as follows: average Quantity Converted in the first [***] post validation batches /average Quantity Dispensed in the first [***]post validation [***] batches * 100 (the “Adjusted Target Yield”).
iii. Without limiting Client’s other rights or remedies, if AAY falls more than [***] below the Adjusted Target Yield in a Contract Year in which Client Processes as least [***] batches of Product for Client, then within [***]...
API Yield. (a) Yield-Related Reports. Patheon shall submit yield-related reports for each Drug Product containing such information and at such times as described in the Yield Calculation Schedule.
(b) Setting the [*] Yield. The Parties shall determine [*] (as [*] defined in the Yield Calculation Schedule which is attached hereto as Schedule B) for a particular Drug Product in accordance with the Yield Calculation Schedule. The Parties may, upon written agreement, adjust such [*] on a Yearly basis to reflect further experience with Actual Yields (as defined in the Yield Calculation Schedule).
API Yield. SEPRACOR’S OBLIGATION 3.1 Payment.
API Yield. After the Commencement Date, Patheon shall provide Sepracor with a quarterly inventory report and reconciliation of the API held by Patheon, which shall contain the following information for such quarter:
API Yield. The following shall apply solely in respect of API provided and paid for by Client. Within sixty (60) days after the end of each Year:
API Yield
