Forecasts and Ordering. Confidential Treatment Requested. (i) Corixa has already submitted to BI Pharma the forecast shown in Exhibit A for the supply of Tositumomab to Amersham, including the supply of Tositumomab designated for use in an Initial Approval Clinical Trial, for the period from the Effective Date until [*] (the "Corixa Forecast"). Within thirty (30) days after the approval by the JDC of the Initial Development Plan, and no later than [*] of each calendar quarter thereafter, Amersham shall furnish to Corixa a written rolling [*] year forecast of its anticipated purchase of bulk Product (including Tositumomab to be used in the manufacture of Corixa Iodine I 131 Tositumomab or Amersham Iodine I 131 Tositumomab) or filled and finished Product for the Territory which shall be consistent with the terms and conditions of the BI Pharma Agreements (the "Amersham Forecast"). Each Amersham Forecast shall cover a [*] year forecast period starting the [*] day of [*] after the quarter in which Amersham provided such Amersham Forecast to Corixa. The Amersham Forecast shall be submitted to Corixa in the format specified in writing by Corixa. Unless the JDC agrees otherwise, Amersham shall include in the Amersham Forecasts and shall specifically identify within the Amersham Forecasts, those quantities of Tositumomab intended for use in an Initial Approval Clinical Trial in the Territory, as decided by the JDC or Corixa pursuant to Section 4.6 of the License Agreement. (ii) Subject to subsection (iii) below, Amersham shall be obligated to purchase from Corixa those portions of the Amersham Forecasts that are binding in accordance with the criteria set forth in Appendix 2B of the BI Pharma Agreement. Amersham shall pay Corixa, in accordance with the terms of Article 4 of this Agreement, for all such quantities of Tositumomab. (iii) Corixa shall be obligated, for the period from the Effective Date until the end of an Initial Approval Clinical Trial, to pay for all Tositumomab designated for use in an Initial Approval Clinical Trial in the Territory, to the extent that such Tositumomab is manufactured pursuant to a binding portion of the Corixa Forecast or an Amersham Forecast. All amounts paid by Corixa pursuant to this subsection 3.1(b)(iii) shall be included in the Development Budget for the Initial Approval Clinical Trials and shall be Initial Approval Trials Costs for the Initial Approval Clinical Trials and subject to the terms and conditions of the License Agreement, including but not limited to Section 5.2(a)(iii) thereof. (iv) In the event that Corixa is informed by BI Pharma that BI Pharma, pursuant to Section 3.1.2 of the BI Pharma supply agreement, will not be able to supply enough Tositumomab to satisfy Amersham's projected requirements for Tositumomab during a particular period, Corixa shall inform Amersham of such projected shortfall and Section 3.1(e) shall apply.
Appears in 1 contract
Forecasts and Ordering. Confidential Treatment Requested(a) At least[***] days prior to the anticipated date of the First Commercial Sale for a Product in the Territory for the Field, Evolus shall prepare and provide Symatese with a written non-binding rolling forecast, on a month-by-month basis, of its total requirement for Products, including desired delivery dates, for the following [****] months (“Products Forecast”). Starting after the First Commercial Sale, on the first Business Day of each month during the Term, Evolus shall submit to Symatese a Products Forecast where the first [***] months of each Products Forecast shall be binding, and the remainder of the Products Forecast shall be non-binding.
(ib) Corixa has already submitted to BI Pharma the forecast shown in Exhibit A Evolus shall submit written purchase orders for the supply of Tositumomab to Amersham, including the supply of Tositumomab designated for use in an Initial Approval Clinical Trial, for the period from the Effective Date until Products (“Purchase Orders”) at least [***] (days prior to the "Corixa Forecast")requested shipment date for such Purchase Order. Within thirty (30) days after the approval Any Purchase Order may be amended solely by the JDC written agreement of the Initial Development Plan, and no later than [*] of each calendar quarter thereafter, Amersham shall furnish to Corixa a written rolling [*] year forecast of its anticipated purchase of bulk Product (including Tositumomab to be used in the manufacture of Corixa Iodine I 131 Tositumomab or Amersham Iodine I 131 Tositumomab) or filled and finished Product for the Territory which shall be consistent with the Parties. No terms and conditions contained in any Purchase Order, acknowledgment, invoice, bill of the BI Pharma Agreements (the "Amersham Forecast"). Each Amersham Forecast shall cover a [*] year forecast period starting the [*] day of [*] after the quarter in which Amersham provided such Amersham Forecast to Corixa. The Amersham Forecast lading, acceptance or other preprinted form issued by either Party shall be submitted effective to Corixa the extent such terms or conditions are inconsistent with or modify any term or condition contained in the format specified this Agreement unless explicitly approved in writing by Corixa. Unless the JDC agrees otherwise, Amersham shall include in the Amersham Forecasts and shall specifically identify within the Amersham Forecasts, those quantities of Tositumomab intended for use in an Initial Approval Clinical Trial in the Territory, as decided by the JDC or Corixa pursuant to Section 4.6 of the License Agreementboth Parties.
(c) Symatese shall notify Evolus within [***] days after Symatese receives a Purchase Order from Evolus indicating if Symatese rejects such Purchase Order, otherwise the Purchase Order is deemed accepted. Symatese may accept a Purchase Order by: (i) initiating performance under such Purchase Order; (ii) Subject to subsection accepting full payment from Evolus as consideration for such Purchase Order; or (iii) belowexpressly accepting such Purchase Order in writing. Immediately after acceptance by Symatese, Amersham each Purchase Order shall be obligated to purchase from Corixa those portions of the Amersham Forecasts that are binding in accordance with the criteria set forth in Appendix 2B of the BI Pharma Agreement. Amersham shall pay Corixa, in accordance with the terms of Article 4 of this Agreement, for all such quantities of Tositumomabupon Symatese.
(iiid) Corixa shall be obligated, for the period from the Effective Date until the end of an Initial Approval Clinical Trial, to pay for all Tositumomab designated for use in an Initial Approval Clinical Trial in the Territory, to the extent If Symatese believes that such Tositumomab is manufactured pursuant to a binding portion of the Corixa Forecast or an Amersham Forecast. All amounts paid by Corixa pursuant to this subsection 3.1(b)(iii) shall be included in the Development Budget for the Initial Approval Clinical Trials and shall be Initial Approval Trials Costs for the Initial Approval Clinical Trials and subject to the terms and conditions of the License Agreement, including but not limited to Section 5.2(a)(iii) thereof.
(iv) In the event that Corixa is informed by BI Pharma that BI Pharma, pursuant to Section 3.1.2 of the BI Pharma supply agreement, it will not be able to supply enough Tositumomab to satisfy Amersham's projected Evolus’ requirements for Tositumomab during a particular periodthe Products, Corixa it shall inform Amersham promptly notify Evolus, specifying the reasons for the expected delay and its anticipated duration. In the event of any shortage of Product’s in Symatese’s inventory, Symatese shall, on order by Evolus, ship to Evolus at least as many units of the Product as Symatese ships to any other customer who has historically ordered similar quantities of Products, taking into account all customers’ purchase histories and industries, among other things. If any Product is subject to limited availability at any time and Evolus has placed Purchase Orders for such projected shortfall Product, then either before or after the date such Product becomes subject to limited availability, Symatese agrees to notify Evolus before filling any Purchase Order for such Product, and Section 3.1(e) shall applyEvolus has the right, in its sole discretion and without liability or penalty, to cancel any existing Purchase Order for such Product.
Appears in 1 contract
Samples: License, Supply, and Distribution Agreement (Evolus, Inc.)
Forecasts and Ordering. Confidential Treatment Requested(a) At least [***] days prior to the anticipated date of the First Commercial Sale for a Product in the Territory for the Field, Evolus shall prepare and provide Symatese with a written non-binding rolling forecast, on a month-by-month basis, of its total requirement for Products, including desired delivery dates, for the following [***] months (“Products Forecast”). Starting after the First Commercial Sale, on the first Business Day of each month during the Term, Evolus shall submit to Symatese a Products Forecast a where the first [***] months of each Products Forecast shall be binding, and the remainder of the Products Forecast shall be non-binding.
(ib) Corixa has already submitted to BI Pharma the forecast shown in Exhibit A Evolus shall submit written purchase orders for the supply of Tositumomab to Amersham, including the supply of Tositumomab designated for use in an Initial Approval Clinical Trial, for the period from the Effective Date until Products (“Purchase Orders”) at least [***] (days prior to the "Corixa Forecast")requested shipment date for such Purchase Order. Within thirty (30) days after the approval Any Purchase Order may be amended solely by the JDC written agreement of the Initial Development Plan, and no later than [*] of each calendar quarter thereafter, Amersham shall furnish to Corixa a written rolling [*] year forecast of its anticipated purchase of bulk Product (including Tositumomab to be used in the manufacture of Corixa Iodine I 131 Tositumomab or Amersham Iodine I 131 Tositumomab) or filled and finished Product for the Territory which shall be consistent with the Parties. No terms and conditions contained in any Purchase Order, acknowledgment, invoice, bill of the BI Pharma Agreements (the "Amersham Forecast"). Each Amersham Forecast shall cover a [*] year forecast period starting the [*] day of [*] after the quarter in which Amersham provided such Amersham Forecast to Corixa. The Amersham Forecast lading, acceptance or other preprinted form issued by either Party shall be submitted effective to Corixa the extent such terms or conditions are inconsistent with or modify any term or condition contained in the format specified this Agreement unless explicitly approved in writing by Corixa. Unless the JDC agrees otherwise, Amersham shall include in the Amersham Forecasts and shall specifically identify within the Amersham Forecasts, those quantities of Tositumomab intended for use in an Initial Approval Clinical Trial in the Territory, as decided by the JDC or Corixa pursuant to Section 4.6 of the License Agreementboth Parties.
(c) Symatese shall notify Evolus within [***] days after Symatese receives a Purchase Order from Evolus indicating if Symatese accepts or rejects such Purchase Order. Symatese may accept a Purchase Order by: (i) initiating performance under such Purchase Order; (ii) Subject to subsection accepting full payment from Evolus as consideration for such Purchase Order; or (iii) belowexpressly accepting such Purchase Order in writing. Immediately after acceptance by Symatese, Amersham each Purchase Order shall be obligated to purchase from Corixa those portions of the Amersham Forecasts that are binding in accordance with the criteria set forth in Appendix 2B of the BI Pharma Agreement. Amersham shall pay Corixa, in accordance with the terms of Article 4 of this Agreement, for all such quantities of Tositumomabupon Symatese.
(iiid) Corixa shall be obligated, for the period from the Effective Date until the end of an Initial Approval Clinical Trial, to pay for all Tositumomab designated for use in an Initial Approval Clinical Trial in the Territory, to the extent If Symatese believes that such Tositumomab is manufactured pursuant to a binding portion of the Corixa Forecast or an Amersham Forecast. All amounts paid by Corixa pursuant to this subsection 3.1(b)(iii) shall be included in the Development Budget for the Initial Approval Clinical Trials and shall be Initial Approval Trials Costs for the Initial Approval Clinical Trials and subject to the terms and conditions of the License Agreement, including but not limited to Section 5.2(a)(iii) thereof.
(iv) In the event that Corixa is informed by BI Pharma that BI Pharma, pursuant to Section 3.1.2 of the BI Pharma supply agreement, it will not be able to supply enough Tositumomab to satisfy Amersham's projected Evolus’ requirements for Tositumomab during a particular periodthe Products, Corixa it shall inform Amersham promptly notify Evolus, specifying the reasons for the expected delay and its anticipated duration. In the event of any shortage of Product’s in Symatese’s inventory, Symatese shall, on order by Evolus, ship to Evolus at least as many units of the Product as Symatese ships to any other customer who has historically ordered similar quantities of Products, taking into account all customers’ purchase histories and industries, among other things. If any Product is subject to limited availability at any time and Evolus has placed Purchase Orders for such projected shortfall Product, then either before or after the date such Product becomes subject to limited availability, Symatese agrees to notify Evolus before filling any Purchase Order for such Product, and Section 3.1(e) shall applyEvolus has the right, in its sole discretion and without liability or penalty, to cancel any existing Purchase Order for such Product.
Appears in 1 contract
Samples: License, Supply, and Distribution Agreement (Evolus, Inc.)
Forecasts and Ordering. Confidential Treatment Requested.
(i) Corixa has already submitted to BI Pharma the forecast shown in Exhibit A for the supply of Tositumomab to Amersham, including the supply of Tositumomab designated for use in an Initial Approval Clinical Trial, for the period from the Effective Date until Within [*] (the "Corixa Forecast"). Within thirty (30) days after the approval by the JDC of the Initial Development Plan, and no later than [*] of each calendar quarter thereafter, Amersham shall furnish to provide Corixa a written rolling [*] year forecast of with its anticipated purchase of bulk Product (including Tositumomab to be used in the manufacture of projected requirements for Corixa Iodine I 131 Tositumomab or Amersham Iodine I 131 Tositumomab) or filled and finished Product for the Territory which shall be consistent with the terms and conditions of the BI Pharma Agreements (the "Amersham Forecast"). Each Amersham Forecast shall cover a through [*] year forecast period starting in accordance with the [*] day of [*] after the quarter in which Amersham provided such Amersham Forecast to Corixa. The Amersham Forecast shall be submitted to Corixa mechanism set forth in the format specified in writing by CorixaSection 3.1(b). Unless the JDC agrees otherwise, Amersham shall include in the Amersham Forecasts all of its forecasts and shall firm orders and specifically identify within the Amersham Forecastssuch forecasts and firm orders, those quantities of Corixa Iodine I 131 Tositumomab intended for use in an Initial Approval Clinical Trial in the Territory, as decided by the JDC or Corixa pursuant to Section 4.6 of the License Agreement. Amersham shall update such forecast for its entire projected requirements of Corixa Iodine I 131 Tositumomab quarterly. Such forecasts shall be consistent with the quantities of Corixa I 131 Tositumomab set forth in Section 3.2(b).
(ii) Subject to subsection (iii) belowOn the Effective Date and on the first day of each month thereafter, Amersham will submit a rolling [*] month forecast to Corixa for Corixa I 131 Tositumomab in the Territory (the "Corixa I 131 Tositumomab Forecast"). The Corixa I 131 Tositumomab Forecast shall be obligated to purchase from consistent with (A) the forecasting and ordering mechanisms required under the Nordion Agreements and (B) the quantities of Corixa those portions of the Amersham Forecasts that are binding in accordance with the criteria I 131 Tositumomab set forth in Appendix 2B of the BI Pharma AgreementSection 3.2(b). Amersham Each Corixa I 131 Tositumomab Forecast shall pay Corixacover, in accordance with weekly amounts, the terms of Article 4 of this Agreement, for all [*] months that follow the month in which such quantities of Tositumomabforecast was submitted to Corixa.
(iii) Corixa shall be obligated, for Every Monday during the period from the Effective Date until the end of an Initial Approval Clinical Trialthat Corixa is supplying Corixa Iodine I 131 Tositumomab to Amersham, to pay Amersham shall place a firm order for all Corixa Iodine I 131 Tositumomab that it wishes to receive, including for so long as applicable the Corixa Iodine I 131 Tositumomab designated for use in an Initial Approval Clinical Trial in Trial, during the Territory, to week that is [*] after the extent that week of such Tositumomab is manufactured pursuant to a binding portion of the Corixa Forecast or an Amersham Forecastfirm order. All amounts paid by Corixa pursuant to this subsection 3.1(b)(iii) Such firm order shall be included consistent with the quantities of Corixa I 131 Tositumomab set forth in the Development Budget for the Initial Approval Clinical Trials Section 3.2(b) and shall be Initial Approval Trials Costs for the Initial Approval Clinical Trials and subject considered binding on Amersham. Subject to the terms and conditions of the License Agreementnext sentence, including but not limited to Section 5.2(a)(iii) thereof.
(iv) In the event that Amersham shall pay for all Corixa is informed by BI Pharma that BI Pharma, Iodine I 131 Tositumomab delivered pursuant to Section 3.1.2 of the BI Pharma supply agreement, will not be able to supply enough Tositumomab to satisfy Amersham's projected requirements for Tositumomab during such a particular period, Corixa shall inform Amersham of such projected shortfall and Section 3.1(e) shall applyfirm order in accordance with -------- * Confidential Treatment Requested.
Appears in 1 contract
Forecasts and Ordering. Confidential Treatment Requested.
(i) Corixa has already submitted to BI Pharma the forecast shown in Exhibit A for the supply of Tositumomab to Amersham, including the supply of Tositumomab designated for use in an Initial Approval Clinical Trial, for the period from the Effective Date until [*] (the "Corixa Forecast"). Within thirty (30) days after the approval by the JDC of the Initial Development Plan, and no later than [*] of each calendar quarter thereafter, Amersham shall furnish to provide Corixa a written rolling [*] year forecast of with its anticipated purchase of bulk Product (including Tositumomab to be used in the manufacture of projected requirements for Corixa * Confidential Treatment Requested Iodine I 131 Tositumomab or Amersham Iodine I 131 Tositumomab) or filled and finished Product for the Territory which shall be consistent through December 31, 2003 in accordance with the terms and conditions of the BI Pharma Agreements (the "Amersham Forecast"). Each Amersham Forecast shall cover a [*] year forecast period starting the [*] day of [*] after the quarter mechanism set forth in which Amersham provided such Amersham Forecast to Corixa. The Amersham Forecast shall be submitted to Corixa in the format specified in writing by CorixaSection 3.1(b). Unless the JDC agrees otherwise, Amersham shall include in the Amersham Forecasts all of its forecasts and shall firm orders and specifically identify within the Amersham Forecastssuch forecasts and firm orders, those quantities of Corixa Iodine I 131 Tositumomab intended for use in an Initial Approval Clinical Trial in the Territory, as decided by the JDC or Corixa pursuant to Section 4.6 of the License Agreement. Amersham shall update such forecast for its entire projected requirements of Corixa Iodine I 131 Tositumomab quarterly. Such forecasts shall be consistent with the quantities of Corixa I 131 Tositumomab set forth in Section 3.2(b).
(ii) Subject to subsection (iii) belowOn the Effective Date and on the first day of each month thereafter, Amersham will submit a rolling two (2) month forecast to Corixa for Corixa I 131 Tositumomab in the Territory (the "Corixa I 131 Tositumomab Forecast"). The Corixa I 131 Tositumomab Forecast shall be obligated to purchase from consistent with (A) the forecasting and ordering mechanisms required under the Nordion Agreements and (B) the quantities of Corixa those portions of the Amersham Forecasts that are binding in accordance with the criteria I 131 Tositumomab set forth in Appendix 2B of the BI Pharma AgreementSection 3.2(b). Amersham Each Corixa I 131 Tositumomab Forecast shall pay Corixacover, in accordance with weekly amounts, the terms of Article 4 of this Agreement, for all two (2) months that follow the month in which such quantities of Tositumomabforecast was submitted to Corixa.
(iii) Corixa shall be obligated, for Every Monday during the period from that Corixa is supplying Corixa Iodine I 131 Tositumomab to Amersham, Amersham shall place a firm order for all Corixa Iodine I 131 Tositumomab that it wishes to receive, including for so long as applicable the Effective Date until the end of Corixa Iodine I 131 Tositumomab designated for use in an Initial Approval Clinical Trial, during the week that is two weeks after the week of such firm order. Such firm order shall be consistent with the quantities of Corixa I 131 Tositumomab set forth in Section 3.2(b) and shall be considered binding on Amersham. Subject to the next sentence, Amersham shall pay for all Corixa Iodine I 131 Tositumomab delivered pursuant to such a firm order in accordance with Article 4. Corixa shall pay for all Corixa Iodine I 131 Tositumomab delivered pursuant to such a firm order that is designated in such firm order for use in an Initial Approval Clinical Trial in the Territory, to the extent that such . Any shortfalls of Corixa I 131 Tositumomab is manufactured pursuant to a binding portion of the Corixa Forecast or an Amersham Forecast. All amounts paid by Corixa pursuant to this subsection 3.1(b)(iii) shall be included handled as set forth in the Development Budget for the Initial Approval Clinical Trials and shall be Initial Approval Trials Costs for the Initial Approval Clinical Trials and subject to the terms and conditions of the License Agreement, including but not limited to Section 5.2(a)(iii) thereof3.11.
(iv) In the event that Corixa is informed by BI Pharma that BI Pharma, pursuant to Section 3.1.2 of the BI Pharma supply agreement, will not be able to supply enough Tositumomab to satisfy Amersham's projected requirements for Tositumomab during a particular period, Corixa shall inform Amersham of such projected shortfall and Section 3.1(e) shall apply.
Appears in 1 contract
Forecasts and Ordering. Confidential Treatment Requested.
(i) Corixa has already submitted to BI Pharma the forecast shown in Exhibit A for the supply of Tositumomab to Amersham, including the supply of Tositumomab designated for use in an Initial Approval Clinical Trial, for the period from the Effective Date until [*] December 31, 2003 (the "Corixa Forecast"). Within thirty (30) days after the approval by the JDC of the Initial Development Plan, and no later than [*] the tenth (10th) day of the second month of each calendar quarter thereafter, Amersham shall furnish to Corixa a written rolling [*] three (3) year forecast of its anticipated purchase of bulk Product (including Tositumomab to be used in the manufacture of Corixa Iodine I 131 Tositumomab or Amersham Iodine I 131 Tositumomab) or filled and finished Product for the Territory which shall be consistent with the terms and conditions of the BI Pharma Agreements (the "Amersham Forecast"). Each Amersham Forecast shall cover a [*] three (3) year forecast period starting the [*] first (1st) day of [*] the second calendar quarter after the quarter in which Amersham provided such Amersham Forecast to Corixa. The Amersham Forecast shall be submitted to Corixa in the format specified in writing by Corixa. Unless the JDC agrees otherwise, Amersham shall include in the Amersham Forecasts and shall specifically identify within the Amersham Forecasts, those quantities of Tositumomab intended for use in an Initial Approval Clinical Trial in the Territory, as decided by the JDC or Corixa pursuant to Section 4.6 of the License Agreement.
(ii) Subject to subsection (iii) below, Amersham shall be obligated to purchase from Corixa those portions of the Amersham Forecasts that are binding in accordance with the criteria set forth in Appendix 2B of the BI Pharma Agreement. Amersham shall pay Corixa, in accordance with the terms of Article 4 of this Agreement, for all such quantities of Tositumomab.
(iii) Corixa shall be obligated, for the period from the Effective Date until the end of an Initial Approval Clinical Trial, to pay for all Tositumomab designated for use in an Initial Approval Clinical Trial in the Territory, to the extent that such Tositumomab is manufactured pursuant to a binding portion of the Corixa Forecast or an Amersham Forecast. All amounts paid by Corixa pursuant to this subsection 3.1(b)(iii) shall be included in the Development Budget for the Initial Approval Clinical Trials and shall be Initial Approval Trials Costs for the Initial Approval Clinical Trials and subject to the terms and conditions of the License Agreement, including but not limited to Section 5.2(a)(iii) thereof.
(iv) In the event that Corixa is informed by BI Pharma that BI Pharma, pursuant to Section 3.1.2 of the BI Pharma supply agreement, will not be able to supply enough Tositumomab to satisfy Amersham's projected requirements for Tositumomab during a particular period, Corixa shall inform Amersham of such projected shortfall and Section 3.1(e) shall apply.
Appears in 1 contract