Quantity Dispensed. The total quantity of Active Materials dispensed at the Manufacturing Site during the applicable period. The Quantity Dispensed is calculated by adding the Quantity Received to the inventory of Active Materials that complies with the Specifications held at the beginning of the applicable period, less the inventory of Active Materials that complies with the Specifications held at the end of the period. The Quantity Dispensed will only include Active Materials received and dispensed in commercial manufacturing of Products, including Active Materials lost in the warehouse prior to and during dispensing, and will not include any (i) Active Materials that must be retained by Patheon as samples, (ii) Active Materials contained in Product that must be retained as samples, (iii) Active Materials used in testing (if applicable), and (iv) Active Materials received or dispensed in 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 Active Materials contained in the Products manufactured with the Quantity Dispensed (including any additional Products produced in accordance with Section 6.3(a) or6.3(b)), delivered by Patheon, and not rejected, recalled or returned in accordance with Section 6.1or 6.2 because of Patheon’s failure to perform the Manufacturing Services in accordance with Specifications, cGMPs, and Applicable Laws. Within 60 days after the end of each Year, Patheon will prepare an annual reconciliation of Active Materials on the reconciliation report form set forth in Exhibit C including the calculation of the "Actual Annual Yield" or "AAY" for the Product at the Manufacturing Site during the Year. AAY is the percentage of the Quantity Dispensed that was converted to Products and is calculated as follows: [***] After Patheon has produced a minimum of [***] successful commercial production batches of Product and has produced commercial production batches for at least [***] months at the Manufacturing Site (collectively, the "Target Yield Determination Batches"), the parties will agree on the target yield for the Product at the Manufacturing Site (each, a "Target Yield"). The Target Yield will be revised annually to reflect the actual manufacturing experience as agreed to by the parties.
Appears in 2 contracts
Samples: Master Manufacturing Services Agreement (Indivior PLC), Master Manufacturing Services Agreement (Indivior PLC)
Quantity Dispensed. The total quantity of Active Materials dispensed at the Manufacturing Site during the applicable period. The Quantity Dispensed is calculated by adding the Quantity Received to the inventory of Active Materials that complies with the Specifications held at the beginning of the applicable period, less the inventory of Active Materials that complies with the Specifications held at the end of the period. The Quantity Dispensed will only include Active Materials received and dispensed in commercial manufacturing of ProductsProducts and, including Active Materials lost in the warehouse prior to and during dispensingfor certainty, and will not include any (i) Active Materials that must be retained by Patheon as samples, (ii) Active Materials contained in Product that must be retained as samples, (iii) Active Materials used in testing (if applicable), and (iv) Active Materials received or dispensed in 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 Active Materials contained in the Products manufactured with the Quantity Dispensed (including any additional Products produced in accordance with Section 6.3(a) or6.3(b)6.1 or 6_2), delivered by Patheon, and not rejected, recalled or returned in accordance with Section 6.1or 6.1 or 6.2 because of Patheon’s failure to perform the Manufacturing Services in accordance with Specifications, cGMPs, and Applicable Laws. Within 60 days […***…] after the end of each Year, Patheon will prepare an annual reconciliation of Active Materials on the reconciliation report form set forth in Exhibit C Schedule I including the calculation of the "“Actual Annual Yield" ” or "“AAY" ” for the Product at the Manufacturing Site during the Year. Year AAY is the percentage of the Quantity Dispensed that was converted to Products and is calculated as follows: [***] Quantity Converted during the Year x 100% Quantity Dispensed during the Year After Patheon has produced a minimum of […***…] successful commercial production batches of Product and or has produced commercial production batches for at least […***…] months at the Manufacturing Site (collectively, the "“Target Yield Determination Batches"”), the parties Parties will mutually agree on the target yield for the Product at the Manufacturing Site (each, a "“Target Yield"”). ; The Target Yield will be revised annually […***…] to reflect the actual manufacturing experience as agreed to by the parties.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Horizon Pharma PLC)
Quantity Dispensed. The total quantity of Active Materials dispensed at the Manufacturing Site during the applicable period. The Quantity Dispensed is calculated by adding the Quantity Received to the inventory of Active Materials that complies with the Specifications held at the beginning of the applicable period, less the inventory of Active Materials that complies with the Specifications held at the end of the period. The Quantity Dispensed will only include Active Materials received and dispensed in commercial manufacturing Manufacturing of Products, including Active Materials lost in the warehouse prior to and during dispensing, dispensing and will not include any (i) Active Materials that must be retained by Patheon as samples, (ii) Active Materials contained in Product that must be retained as samples, (iii) Active Materials used in testing (if applicable), and (iv) Active Materials received or dispensed in technical transfer activities or development activities during the applicable period, including without limitation, any regulatory, stability, validation or test batches manufactured Manufactured during the applicable period. Quantity Converted: The total amount of Active Materials contained in the Products manufactured Manufactured with the Quantity Dispensed (including any additional Products produced in accordance with Section 6.3(a) or6.3(bor Section 6.3(b)), delivered Delivered by Patheon, and not rejected, recalled or returned in accordance with Section 6.1or 6.1 or Section 6.2 because or when, as a result of Patheon’s failure to perform the Manufacturing Services in accordance with Specifications, cGMPs, and Applicable Laws. Laws such failure an Active Material cannot be used in the Manufacturing or supply of a Product; Within 60 days after the end of each Year, Patheon will prepare an annual reconciliation of Active Materials on the reconciliation report form set forth in Exhibit C including the calculation of the "“Actual Annual Yield" ” or "“AAY" ” for the Product at the Manufacturing Site during the Year. AAY is the percentage of the Quantity Dispensed that was converted to Products and is calculated as follows: [***] After Quantity Converted during the Year x 100% Quantity Dispensed during the Year Unless otherwise agreed between the parties in the relevant Product Agreement, after Patheon has produced a minimum of [***] successful ten (10) commercial production batches of Conforming Product which have been accepted by Client in accordance with the terms of this Agreement and has produced commercial production batches of Conforming Products for at least [***] six months at the applicable Manufacturing Site (collectively, the "“Target Yield Determination Batches"”), the parties will agree on the target yield for the Product at the relevant Manufacturing Site (each, a "“Target Yield"”). The Target Yield will be revised annually to reflect the actual manufacturing Manufacturing experience as agreed to by the parties. For the avoidance of doubt, any Batches that have unusually low yields due to deviations from the validated process will be excluded from the Target Yield Determination Batches.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Melinta Therapeutics, Inc. /New/)
Quantity Dispensed. The total quantity of Active Materials dispensed at the Manufacturing Site during the applicable period. The Quantity Dispensed is calculated by adding the Quantity Received to the inventory of Active Materials that complies with the Specifications held at the beginning of the applicable period, less the inventory of Active Materials that complies with the Specifications held at the end of the period. The Quantity Dispensed will only include Active Materials received and dispensed in commercial manufacturing of ProductsProducts and, including Active Materials lost in the warehouse prior to and during dispensingfor certainty, and will not include any (i) Active Materials that must be retained by Patheon as samples, (ii) Active Materials contained in Product that must be retained as samples, (iii) Active Materials used in testing (if applicable), and (iv) Active Materials received or dispensed in 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 Active Materials contained in the Products manufactured with the Quantity Dispensed (including any additional Products produced in accordance with Section 6.3(a) or6.3(b)6.1 or 6.2), delivered by Patheon, and not rejected, recalled or returned in accordance with Section 6.1or 6.1 or 6.2 because of Patheon’s failure to perform the Manufacturing Services in accordance with Specifications, cGMPs, and Applicable Laws. Within 60 sixty (60) days after the end of each Year, Patheon will prepare an annual reconciliation of Active Materials on the reconciliation report form set forth in Exhibit C F including the calculation of the "“Actual Annual Yield" ” or "“AAY" ” for the Product at the Manufacturing Site during the Year. AAY is the percentage of the Quantity Dispensed that was converted to Products and is calculated as follows: [***] Quantity Converted during the Year x 100% Quantity Dispensed during the Year After Patheon has produced a minimum of [***] successful ten (10) commercial production batches of Product and has produced commercial production batches for at least [***] six (6) months at the Manufacturing Site (collectively, the "“Target Yield Determination Batches"”), the parties Parties will mutually agree on the target yield for the Product at the Manufacturing Site (each, a "“Target Yield"”). The Target Yield will be revised annually to reflect the actual manufacturing experience as agreed to by the parties.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Avadel Pharmaceuticals PLC)
Quantity Dispensed. The total quantity of Active Materials dispensed at the Manufacturing Site during the applicable period. The Quantity Dispensed is calculated by adding the Quantity Received to the inventory of Active Materials that complies with the Specifications held at the beginning of the applicable period, less the inventory of Active Materials that complies with the Specifications held at the end of the period[*]. The Quantity Dispensed will only include Active Materials received and dispensed in commercial manufacturing of ProductsProducts and, including Active Materials lost in the warehouse prior to and during dispensingfor certainty, and will not include any (i) Active Materials that must be retained by Patheon as samples, (ii) Active Materials contained in Product that must be retained as samples, (iii) Active Materials used in testing (if [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. applicable), and (iv) Active Materials received or dispensed in 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 Active Materials contained in the Products manufactured with the Quantity Dispensed (including any additional Products produced in accordance with Section 6.3(a) or6.3(b)6.1 or 6.2), delivered by Patheon, and not rejected, recalled or returned in accordance with Section 6.1or 6.1 or 6.2 because of Patheon’s failure to perform the Manufacturing Services in accordance with Specifications, cGMPs, and Applicable Laws. Within 60 [*] days after the end of (i) the first Year, and (ii) each [*] ([*]) month interval during each subsequent Year, (each such period in (i) and (ii) a “Reconciliation Interval”), Patheon will prepare an annual a reconciliation of Active Materials on the reconciliation report form set forth in Exhibit C Schedule I including the calculation of the "“Actual Annual Yield" ” or "AAY" “AY” for the Product at the Manufacturing Site during the Reconciliation Interval. However, if the Reconciliation Interval for the first or last Year comprises fewer than [*] ([*]) months, then the months comprising the Reconciliation Interval for the such Year will be combined with the [*] ([*]) months comprising the Reconciliation Interval (i) immediately following the first Year, or (ii) immediately preceding the last Year, as the case may be, for purposes of preparing the reconciliation report. AAY AY is the percentage of the Quantity Dispensed that was converted to Products and is calculated as follows: [**] [*] After Patheon has produced a minimum of [***] successful commercial production batches of all strengths of the Product combined and has produced commercial production batches for at least [***] months at the Manufacturing Site (collectively, the "“Target Yield Determination Batches"”), the parties Parties will mutually agree on the target yield for the Product at the Manufacturing Site (each, a "“Target Yield"”). The Target Yield will be revised annually to reflect target yield determination batches shall not include any batches that in Patheon and the actual manufacturing experience as agreed to by the parties.Client’s reasonable judgement were produced in production runs involving technical difficulties or involving extraordinary loss of Active Materials;
Appears in 1 contract
Samples: Manufacturing Services Agreement (Chelsea Therapeutics International, Ltd.)
Quantity Dispensed. The total quantity of Active Materials dispensed at the Manufacturing Site during the applicable period. The Quantity Dispensed is calculated by adding the Quantity Received to the inventory of Active Materials that complies with the Specifications held at the beginning of the applicable period, less the inventory of Active Materials that complies with the Specifications held at the end of the period. The Quantity Dispensed will only include Active Materials received and dispensed in commercial manufacturing of ProductsProducts and, including Active Materials lost in the warehouse prior to and during dispensingfor certainty, and will not include any (i) Active Materials that must be retained by Patheon as samples, (ii) Active Materials contained in Product that must be retained as samples, (iii) Active Materials used in testing (if applicable), and (iv) Active Materials received or dispensed in 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 Active Materials contained in the Products manufactured with the Quantity Dispensed (including any additional Products produced in accordance with Section 6.3(a) or6.3(bor 6.3(b)), delivered by Patheon, and not rejected, recalled or returned in accordance with Section 6.1or 6.2 because of Patheon’s failure to perform the Manufacturing Services in accordance with Specifications, cGMPs, and Applicable Laws. Within 60 days after the end of each Year, Patheon will prepare an annual reconciliation of Active Materials on the reconciliation report form set forth in Exhibit C D including the calculation of the "Actual Annual Yield" or "AAY" for the Product at the Manufacturing Site during the Year. AAY is the percentage of the Quantity Dispensed that was converted to Products and is calculated as follows: [***] Quantity Converted during the Year x 100% Quantity Dispensed during the Year After Patheon has produced a minimum of [***] 25 successful commercial production batches of Product and or has produced commercial production batches for at least [***] six months at the Manufacturing Site (collectively, the "Target Yield Determination Batches"), the parties will agree on the target yield for the Product at the Manufacturing Site (each, a "Target Yield"). The Target Yield will be revised annually to reflect the actual manufacturing experience as agreed to by the parties.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (TESARO, Inc.)