Supply of Materials. (a) If Ascent chooses to supply any material for the manufacture of Products as set forth under this Section II, Ascent shall notify Upshxx-Xxxxx xx writing, specifying which materials it intends to supply. Ascent shall provide Upshxx-Xxxxx xxxh said material at Ascent's expense along with Certificates of Analysis relating to such materials, at a minimum of thirty (30) days prior to scheduled production of Product requiring such material and in sufficient amounts for Upshxx-Xxxxx'x xxxufacture of Product, but not to exceed quantities necessary to support three (3) months of the most recently supplied Forecasted Needs or the lot size quantity, whichever is greater. Ascent-supplied material in excess of these amounts shall be either subject to storage fees or returned to Ascent. Upshxx-Xxxxx xx hereby authorized by Ascent, after reasonable advance notice to Ascent, to return any portion of Ascent-supplied material for which no future production is planned. Ascent shall be responsible for the supply and quality of said materials. Ascent shall be responsible for the payment of all personal property and other taxes incident to the storage of Ascent-owned material at Upshxx-Xxxxx, xxter receipt of documentation thereof reasonably acceptable to Ascent. For each lot of materials supplied by Ascent, Upshxx-Xxxxx xxxll perform the quality control and inspection tests as agreed to in the Specifications unless Ascent has made arrangements in writing for Pre-Approved material. Upshxx-Xxxxx xxxll have the right to reject any Pre-Approved material which is tested pursuant to Section 2.3 below and does not meet the Specifications. Upshxx-Xxxxx xxxrants that it will maintain, for the benefit of Ascent, complete and accurate records of the inventory of all such Ascent-supplied raw materials. Upshxx-Xxxxx xxxl use reasonable efforts to avoid the commingling of Ascent-supplied raw materials with any other raw materials and to avoid use of Ascent raw materials obtained pursuant to this Agreement for any purpose not directly related to the completion of this Agreement. If requested by Ascent, Upshxx-Xxxxx xxxl provide to Ascent a monthly report limited to ending monthly inventory balance of each Ascent-supplied/owned material stored at Upshxx-Xxxxx. Xxis reporting will be supplied exclusively on Upshxx-Xxxxx xxxms.
Appears in 2 contracts
Samples: Asset Purchase Agreement (Ascent Pediatrics Inc), Asset Purchase Agreement (Ascent Pediatrics Inc)
Supply of Materials. (a) If Ascent chooses LONZA shall supply, at its expense, all Materials necessary to supply Manufacture each Product other than the PCYC Materials. PCYC shall supply, at its expense, all PCYC Materials necessary to Manufacture each Product hereunder. PCYC shall deliver or cause to be delivered a reasonably sufficient amount of each of the applicable PCYC Materials for each Product to be Manufactured hereunder to the applicable Facility sufficiently in advance of the time that such PCYC Materials will be required for use in the Manufacture of such Product under the applicable Purchase Order. Such required advance times and amounts shall be set forth in the applicable Product Appendix, as well as any material applicable storage requirements for such PCYC Materials. Upon receipt of the manufacture of Products PCYC Materials as set forth under this Section IIabove, Ascent LONZA shall notify Upshxx-Xxxxx xx writingreview the accompanying certificate(s) of analysis and test the PCYC Materials for conformance with the applicable Identification Testing Standards, specifying which materials it intends in accordance with the analytical test methods set forth in the applicable Product Appendix. Both such Identification Testing Standards and related analytical test methods may be amended from time to supplytime upon mutual written agreement of PCYC and LONZA. Ascent shall provide Upshxx-Xxxxx xxxh said material at Ascent's expense along with Certificates Within [ *** ] of Analysis relating to such materials, at a minimum of thirty (30) days prior to scheduled production of Product requiring such material and in sufficient amounts for Upshxx-Xxxxx'x xxxufacture of Product, but not to exceed quantities necessary to support three (3) months receipt of the most recently supplied Forecasted Needs PCYC Materials described in Section 3.2.2, or such other period as may be specified in the lot size quantityapplicable Product Appendix, whichever is greaterLONZA shall determine if such PCYC Materials meet the applicable Identification Testing Standards. Ascent-supplied material in excess of these amounts If LONZA determines that such PCYC Materials meet the Identification Testing Standards, then such PCYC Materials shall be either subject to storage fees or returned to Ascent. Upshxx-Xxxxx xx hereby authorized used by Ascent, after reasonable advance notice to Ascent, to return any portion of Ascent-supplied material for which no future production is planned. Ascent shall be responsible for the supply and quality of said materials. Ascent shall be responsible for the payment of all personal property and other taxes incident to the storage of Ascent-owned material at Upshxx-Xxxxx, xxter receipt of documentation thereof reasonably acceptable to Ascent. For each lot of materials supplied by Ascent, Upshxx-Xxxxx xxxll perform the quality control and inspection tests as agreed to LONZA in the Specifications unless Ascent has made arrangements in writing for Pre-Approved material. Upshxx-Xxxxx xxxll have the right to reject any Pre-Approved material which is tested pursuant to Section 2.3 below and does not meet the Specifications. Upshxx-Xxxxx xxxrants that it will maintain, for the benefit of Ascent, complete and accurate records of the inventory of all such Ascent-supplied raw materials. Upshxx-Xxxxx xxxl use reasonable efforts to avoid the commingling of Ascent-supplied raw materials with any other raw materials and to avoid use of Ascent raw materials obtained pursuant to this Agreement for any purpose not directly related to the completion of performing its Manufacturing obligations under this Agreement. If requested LONZA determines that any such PCYC Materials do not meet the Identification Testing Standards, then LONZA shall make no use of such non-conforming PCYC Materials and shall promptly confer with PCYC to determine how to proceed. LONZA shall return, rework or destroy any non-conforming PCYC Materials as directed by AscentPCYC in writing and at PCYC's expense. From the time of delivery of the PCYC Materials to LONZA until the earlier of (a) delivery by LONZA of Product, Upshxx-Xxxxx xxxl provide or (b) return or destruction of the PCYC Materials by LONZA that do not meet the Identification Testing Standards, each in the manner provided in this Agreement, LONZA shall bear all risk of loss of such PCYC Materials. LONZA shall comply with all applicable laws, rules, regulations and guidelines in the use, storage, handling and transportation of the PCYC Materials. PCYC shall retain all right, title and interest in and to Ascent all PCYC Materials at all times. If PCYC fails to deliver to LONZA the PCYC Materials necessary to fulfill a monthly report limited Purchase Order submitted by PCYC and accepted by LONZA in accordance with Section 3.4.2, in the quantities and time frame described in Section 3.2.2, or if LONZA determines in accordance with Section 3.2.4 that such PCYC Materials do not meet the applicable Identification Testing Standards, then: PCYC may, at its election, cancel such Purchase Order, with the effect set forth in Section 3.5; or PCYC may request that LONZA reschedule the manufacturing campaign for such Purchase Order, and LONZA shall use reasonable, good faith efforts to ending monthly inventory balance fulfill such request. To the extent that such rescheduling directly results in the plant capacity reserved for the fulfillment of each Ascent-supplied/owned material stored at Upshxx-Xxxxxsuch Purchase Order being unutilized, PCYC shall reimburse LONZA for such unutilized capacity in accordance with Section 3.5.2. Xxis reporting will If LONZA does not reject, in writing, PCYC's request to reschedule such manufacturing campaign within [ *** ] following LONZA's receipt of PCYC's written request, then LONZA shall be supplied exclusively on Upshxx-Xxxxx xxxmsdeemed to have accepted such request. If LONZA rejects PCYC's request to reschedule such manufacturing campaign, then such Purchase Order shall be deemed to have been cancelled, with the effect set forth in Section 3.5.
Appears in 1 contract
Samples: Supply Agreement (Pharmacyclics Inc)
Supply of Materials. (a) If Ascent chooses XXXXX shall supply, at its expense, all Materials necessary to supply Manufacture each Product other than the PCYC Materials. PCYC shall supply, at its expense, all PCYC Materials necessary to Manufacture each Product hereunder. PCYC shall deliver or cause to be delivered a reasonably sufficient amount of the applicable PCYC Materials for each Product to be Manufactured hereunder to the applicable Facility sufficiently in advance of the date of delivery set forth in the applicable Purchase Order such that XXXXX can fill such Purchase Orders, which required advance time, as well as any material storage requirements for such PCYC Materials, shall be set forth in the manufacture applicable Product Appendix. Upon receipt of Products the PCYC Materials as set forth under this Section IIabove, Ascent XXXXX shall notify Upshxx-Xxxxx xx writingreview the accompanying certificate(s) of analysis and test the PCYC Materials for conformance with the Identification Testing Standards, specifying which materials it intends in accordance with the analytical test methods set forth in the applicable Product Appendix. Both the Identification Testing Standards and related analytical test methods may be amended from time to supplytime upon mutual written agreement of PCYC and XXXXX. Ascent shall provide Upshxx-Xxxxx xxxh said material at Ascent's expense along with Certificates Within [ *** ] of Analysis relating to such materials, at a minimum of thirty (30) days prior to scheduled production of Product requiring such material and in sufficient amounts for Upshxx-Xxxxx'x xxxufacture of Product, but not to exceed quantities necessary to support three (3) months receipt of the most recently supplied Forecasted Needs PCYC Materials described in Section 3.3.1, or such other period as may be specified in the lot size quantityapplicable Product Appendix, whichever is greaterXXXXX shall determine if such PCYC Materials meet the applicable Identification Testing Standards. Ascent-supplied material in excess of these amounts If XXXXX determines that such PCYC Materials meet the Identification Testing Standards, then such PCYC Materials shall be either subject to storage fees or returned to Ascent. Upshxx-Xxxxx xx hereby authorized used by Ascent, after reasonable advance notice to Ascent, to return any portion of Ascent-supplied material for which no future production is planned. Ascent shall be responsible for the supply and quality of said materials. Ascent shall be responsible for the payment of all personal property and other taxes incident to the storage of Ascent-owned material at Upshxx-Xxxxx, xxter receipt of documentation thereof reasonably acceptable to Ascent. For each lot of materials supplied by Ascent, Upshxx-Xxxxx xxxll perform the quality control and inspection tests as agreed to XXXXX in the Specifications unless Ascent has made arrangements in writing for Pre-Approved material. Upshxx-Xxxxx xxxll have the right to reject any Pre-Approved material which is tested pursuant to Section 2.3 below and does not meet the Specifications. Upshxx-Xxxxx xxxrants that it will maintain, for the benefit of Ascent, complete and accurate records of the inventory of all such Ascent-supplied raw materials. Upshxx-Xxxxx xxxl use reasonable efforts to avoid the commingling of Ascent-supplied raw materials with any other raw materials and to avoid use of Ascent raw materials obtained pursuant to this Agreement for any purpose not directly related to the completion of performing its Manufacturing obligations under this Agreement. If requested XXXXX determines that any such PCYC Materials do not meet the Identification Testing Standards, then XXXXX shall make no use of such non-conforming PCYC Materials and shall promptly confer with PCYC to determine how to proceed. XXXXX shall return, rework or destroy any non-conforming PCYC Materials as directed by AscentPCYC in writing and at PCYC's expense. From the time of delivery of the PCYC Materials to XXXXX until the earlier of (a) delivery by XXXXX of Product, Upshxx-Xxxxx xxxl provide or (b) return or destruction of the PCYC Materials by XXXXX that do not meet the Identification Testing Standards, each in the manner provided in this Agreement, XXXXX shall bear all risk of loss of such PCYC Materials. XXXXX shall comply with all applicable laws, rules, regulations and guidelines in the use, storage, handling and transportation of the PCYC Materials. PCYC shall retain all right, title and interest in and to Ascent a monthly report limited to ending monthly inventory balance of each Ascent-supplied/owned material stored all PCYC Materials at Upshxx-Xxxxxall times. Xxis reporting will be supplied exclusively on Upshxx-Xxxxx xxxms.Forecasts. [ *** ]
Appears in 1 contract
Samples: Supply Agreement (Pharmacyclics Inc)
Supply of Materials. (a) If Ascent chooses DOTTIKON shall supply, at its expense, all Materials necessary to supply Manufacture each Product other than the PCYC Materials. PCYC shall supply, at its expense, all PCYC Materials necessary to Manufacture each Product hereunder. PCYC shall deliver or cause to be delivered a reasonably sufficient amount of the applicable PCYC Materials for each Product to be Manufactured hereunder to the applicable Facility sufficiently in advance of the date of delivery set forth in the applicable Purchase Order such that DOTTIKON can fill such Purchase Orders, which required advance time, as well as any material storage requirements for such PCYC Materials, shall be set forth in the manufacture applicable Product Appendix. Upon receipt of Products the PCYC Materials as set forth under this Section IIabove, Ascent DOTTIKON shall notify Upshxx-Xxxxx xx writingreview the accompanying certificate(s) of analysis and test the PCYC Materials for conformance with the Identification Testing Standards, specifying which materials it intends in accordance with the analytical test methods set forth in the applicable Product Appendix. Both the Identification Testing Standards and related analytical test methods may be amended from time to supplytime upon mutual written agreement of PCYC and DOTTIKON. Ascent shall provide Upshxx-Xxxxx xxxh said material at Ascent's expense along with Certificates Within [ *** ] of Analysis relating to such materials, at a minimum of thirty (30) days prior to scheduled production of Product requiring such material and in sufficient amounts for Upshxx-Xxxxx'x xxxufacture of Product, but not to exceed quantities necessary to support three (3) months receipt of the most recently supplied Forecasted Needs PCYC Materials described in Section 3.3.1, or such other period as may be specified in the lot size quantityapplicable Product Appendix, whichever is greaterDOTTIKON shall determine if such PCYC Materials meet the applicable Identification Testing Standards. Ascent-supplied material in excess of these amounts If DOTTIKON determines that such PCYC Materials meet the Identification Testing Standards, then such PCYC Materials shall be either subject to storage fees or returned to Ascent. Upshxx-Xxxxx xx hereby authorized used by Ascent, after reasonable advance notice to Ascent, to return any portion of Ascent-supplied material for which no future production is planned. Ascent shall be responsible for the supply and quality of said materials. Ascent shall be responsible for the payment of all personal property and other taxes incident to the storage of Ascent-owned material at Upshxx-Xxxxx, xxter receipt of documentation thereof reasonably acceptable to Ascent. For each lot of materials supplied by Ascent, Upshxx-Xxxxx xxxll perform the quality control and inspection tests as agreed to DOTTIKON in the Specifications unless Ascent has made arrangements in writing for Pre-Approved material. Upshxx-Xxxxx xxxll have the right to reject any Pre-Approved material which is tested pursuant to Section 2.3 below and does not meet the Specifications. Upshxx-Xxxxx xxxrants that it will maintain, for the benefit of Ascent, complete and accurate records of the inventory of all such Ascent-supplied raw materials. Upshxx-Xxxxx xxxl use reasonable efforts to avoid the commingling of Ascent-supplied raw materials with any other raw materials and to avoid use of Ascent raw materials obtained pursuant to this Agreement for any purpose not directly related to the completion of performing its Manufacturing obligations under this Agreement. If requested DOTTIKON determines that any such PCYC Materials do not meet the Identification Testing Standards, then DOTTIKON shall make no use of such non-conforming PCYC Materials and shall promptly confer with PCYC to determine how to proceed. DOTTIKON shall return, rework or destroy any non-conforming PCYC Materials as directed by AscentPCYC in writing and at PCYC's expense. From the time of delivery of the PCYC Materials to DOTTIKON until the earlier of (a) delivery by DOTTIKON of Product, Upshxx-Xxxxx xxxl provide or (b) return or destruction of the PCYC Materials by DOTTIKON that do not meet the Identification Testing Standards, each in the manner provided in this Agreement, DOTTIKON shall bear all risk of loss of such PCYC Materials. DOTTIKON shall comply with all applicable laws, rules, regulations and guidelines in the use, storage, handling and transportation of the PCYC Materials. PCYC shall retain all right, title and interest in and to Ascent a monthly report limited to ending monthly inventory balance of each Ascent-supplied/owned material stored all PCYC Materials at Upshxx-Xxxxx. Xxis reporting will be supplied exclusively on Upshxx-Xxxxx xxxmsall times.
Appears in 1 contract
Samples: Supply Agreement (Pharmacyclics Inc)