Quantity Dispensed definition
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 and, for certainty, 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 Dispensed has the meaning specified in Section 2.2(a);
Quantity Dispensed means the total quantity of API dispensed at the MOVA Facility during the applicable period. The Quantity Dispensed is calculated by adding the Quantity Received to the existing inventory of API that complied with the Specifications for API upon receipt by MOVA and is held at the beginning of the applicable period, less the inventory of API that is held at the end of such period. The Quantity Dispensed shall only include API received and dispensed in connection with commercial manufacturing of Products and, for certainty, shall not include any (i) API that must be retained by MOVA as samples pursuant to this Agreement, the Quality Agreement or applicable regulatory requirements, (ii) API contained in Product that must be retained as samples pursuant to this Agreement, the Quality Agreement or applicable regulatory requirements, (iii) API used in connection with testing by or on behalf of MOVA or DEPOMED in the performance of this Agreement or the Quality Agreement (if applicable) and (iv) API 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 and required in the performance of this Agreement, the Quality Agreement or pursuant to Applicable Law.
Examples of Quantity Dispensed in a sentence
Without limiting Client's other rights or remedies, if AAY falls more than [***] below Target Yield in a Contract Year in which Client Processes and/or Packages at least [***] batches of Product for Client, then within [***] days after the end of the applicable Contract Year, Catalent will credit to Client's account the amount of the shortfall, calculated as follows: For non-packaged Product: [(Target Yield - [***]) - AAY] * API cost * Quantity Dispensed.
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.
Without limiting Client’s other rights or remedies, if AAY falls more than [***] percent ([***]%) below the Initial or Adjusted Target Yield in a Contract Year in which Client Processes as least [***] batches of Product for Client, then within [***] days after the end of the applicable Contract Year, Catalent will credit to Client’s account the amount of the shortfall, calculated as follows: [(Initial or Adjusted Target Yield – [***]%) – AAY] * API cost * Quantity Dispensed.
Adjusted Target Yield - will be the actual average yield of the initial [***] 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”).
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”).
More Definitions of Quantity Dispensed
Quantity Dispensed. The Quantity Dispensed for the calendar month is calculated by adding the Quantity Received during the calendar month to the inventory of Active Materials that complied with the Specifications held at the beginning of the calendar month and then subtracting from the resulting sum the sum of (A) the inventory of Active Materials that complied with the Specifications held at the end of the calendar month plus [*****].
Quantity Dispensed which shall mean the total quantity of API dispensed at the Patheon Facility during the applicable month. The Quantity Dispensed is calculated by adding the Quantity Received to the existing inventory of API that complied with the specifications for API upon receipt by Patheon and is held at the beginning of the applicable month, less the inventory of API that is held by Patheon at the end of such month. The Quantity Dispensed shall only include API received and dispensed in connection with the manufacture of Product and shall not include any API (a) that must be retained by Patheon as samples, pursuant to this Agreement, the Quality Agreement or Applicable Laws, (b) contained in Product that must be retained as samples pursuant to this Agreement, the Quality Agreement or Applicable Laws, (c) used in connection with testing, by or on behalf of Patheon or Depomed, in the performance of this Agreement or the Quality Agreement (if applicable) and (d) dispensed at Depomed’s request 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 and required in the performance of this Agreement, the Quality Agreement or pursuant to Applicable Laws.
Quantity Dispensed has the meaning specified in Section 3.11;
Quantity Dispensed. The total quantity of Active Materials dispensed at the Manufacturing Site during the applicable quarter. The Quantity Dispensed for each applicable quarter is calculated by adding the Quantity Received during the applicable quarter to the inventory of Active Materials that complied with the Specifications held at the beginning of the applicable quarter, less the inventory of Active Materials that complied with the Specifications held at the end of the quarter. The Quantity Dispensed during each applicable quarter will only include Active Materials received and dispensed in commercial manufacturing of Products and, for certainty, 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 quarter, including without limitation, any regulatory, stability, validation or test batches manufactured during the applicable quarter.
Quantity Dispensed. The total quantity of Active Material dispensed from inventory at the Manufacturing Site in connection with commercial manufacturing of Product, less any (A) Active Material that must be retained by AAA as samples and stability, (B) Active Material contained in Product that must be retained as samples, (C) Active Material used in connection with testing (if applicable) and (D) Active Material received or consumed in connection with technical transfer activities or development activities, including any regulatory, stability, validation, or test batches manufactured; and
Quantity Dispensed. The total quantity of Active Materials dispensed at the Manufacturing Site during the applicable month (“Quantity Dispensed”). The Quantity Dispensed is calculated by adding the Quantity Received to the inventory of Active Materials that complies with the Specifications and is held by Patheon at the beginning of the applicable month, less the inventory of Active Materials that complies with the Specifications and is held by Patheon at the end of the month. The Quantity Dispensed will only include Active Materials received and dispensed in commercial manufacturing of Products 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, in each case of clauses (i) through (iv) in accordance with this Agreement. Client acknowledges that, if there is no change in this information from one month to the next month, the report will reflect that. Within […***…] 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 each Manufacturing Site during the Year. AAY is the percentage of the Quantity Dispensed that was converted to Product and is calculated as follows: Quantity Converted during the Yearx100% Quantity Dispensed during the Year 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. Additionally, promptly following production of the validation Batches, but prior to production of the […***…] Target Yield Determination Batches described above, the Parties will agree to an interim Target Yield that will apply before determination of the ...
Quantity Dispensed means the total quantity of API dispensed at the Facility during the applicable period. The Quantity Dispensed is calculated by adding the Quantity Received to the inventory of API that complies with the Specifications held at the beginning of the applicable period, less the inventory of API that complies with the Specifications held at the end of such period. The Quantity Dispensed shall only include API received and dispensed in connection with commercial manufacturing of Products and, for certainty, shall not include any 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.