Materials Supplied by COMPANY. If COMPANY is to supply any material for manufacture of Products as set forth under this Section, COMPANY shall notify DPT, in writing, specifying which materials it will supply. COMPANY shall provide DPT with said materials at COMPANY’s expense along with Certificates of Analysis and MSDS sheets relating to same, at a minimum of thirty (30) days prior to DPT’s scheduled production of Product requiring said materials and in sufficient amounts for DPT’s manufacture of Product but not to exceed quantities necessary to support four (4) months of the most recently supplied Forecasted Needs or the minimum order quantity whichever is greater. COMPANY supplied material in excess of these amounts shall be either subject to storage fees or returned to COMPANY. All COMPANY supplied material shall be shipped to DPT freight prepaid. In the event COMPANY ships or causes to ship such material freight collect, DPT shall invoice COMPANY for the cost of the freight plus a reasonable administrative fee which invoice shall be paid promptly upon receipt. DPT is hereby authorized by COMPANY to return any portion of COMPANY supplied material for which no future production is planned. COMPANY shall be responsible for the quality of all COMPANY-supplied materials. COMPANY shall be responsible for the payment of all personal property and other taxes incident to the storage of COMPANY-owned material at DPT. For each lot of materials supplied by COMPANY, DPT shall perform the quality control and inspection tests as agreed to in the Specifications unless COMPANY has made arrangements in writing for pre-approved material. DPT shall have the right to reject any pre-approved material which does not meet the Specifications in accordance with paragraph 2.3 below. DPT warrants that it will maintain, for the benefit of COMPANY, complete and accurate records of the inventory of all such COMPANY-supplied materials. If requested by COMPANY, DPT will provide to COMPANY a monthly report of ending monthly inventory balance of each COMPANY supplied/owned materials stored at DPT. This reporting will be supplied exclusively on DPT forms.
Appears in 4 contracts
Samples: Manufacturing Agreement (Insys Therapeutics, Inc.), Manufacturing Agreement (Insys Therapeutics, Inc.), Manufacturing Agreement (Insys Therapeutics, Inc.)
Materials Supplied by COMPANY. If COMPANY is to supply any material for manufacture Manufacture of Products Product as set forth under this SectionSection 2.2, such material shall be described in Schedule C (“COMPANY Material”). COMPANY shall notify DPTRENAISSANCE, in writing, specifying which materials it will supply. writing of any changes or amendments to Schedule C. COMPANY shall provide DPT RENAISSANCE with said materials at COMPANY’s COMPANY Material [***] expense along with Certificates of Analysis and MSDS sheets SDSs relating to same, such COMPANY Material in accordance with Section 2.4 at a minimum of thirty (30) days [***] prior to DPTRENAISSANCE’s scheduled production of Product requiring said materials such COMPANY Material and in sufficient amounts for DPTRENAISSANCE’s manufacture Manufacture of Product Product, but not to exceed the greater of (i) quantities necessary to support four (4) months [***] of the most recently recently-supplied Forecasted Needs or the minimum order quantity whichever is greaterNeeds, and (ii) any [***]. In addition, COMPANY supplied material Material in excess of these amounts [***] of the most recently- supplied Forecast Needs shall be either subject to storage fees in accordance with Schedule D or returned to COMPANY, [***]. All COMPANY supplied material Material shall be shipped to DPT freight prepaidRENAISSANCE [***]. In the event COMPANY ships or causes to ship such material freight collectCOMPANY Material [***], DPT [***] shall invoice COMPANY [***] for the cost of the freight plus a reasonable administrative fee [***], which invoice shall be paid [***] promptly upon receipt. DPT is hereby authorized by COMPANY to return any portion of COMPANY supplied material for which no future production is planned. COMPANY shall be responsible for the quality of all COMPANY-supplied materialsCOMPANY Material. COMPANY shall be responsible for the payment of all personal property [***] and other taxes [***] incident to the storage [***] of COMPANY-owned material at DPTCOMPANY Material delivered to RENAISSANCE. For each lot of materials COMPANY Material supplied by COMPANY, DPT RENAISSANCE shall perform the quality control and inspection tests [***] as agreed to in the Specifications unless COMPANY has made arrangements in writing for pre-approved material[***]. DPT In the event that any COMPANY Material requires RENAISSANCE to [***] that is not included in the Specifications, RENAISSANCE will [***] and may charge COMPANY for those services at the [***]. COMPANY shall deliver all COMPANY Material so that it is received by RENAISSANCE with not less than [***] of shelf life remaining at the time of receipt. RENAISSANCE shall have the right to reject any pre-approved material [***] COMPANY Material which does not meet the Specifications in accordance with paragraph 2.3 belowSection 2.3. DPT To the extent required by Applicable Law, COMPANY is responsible for auditing the facilities of the COMPANY Material, and COMPANY agrees to provide RENAISSANCE, upon RENAISSANCE’s request, a current copy of the audit report of these facilities, subject to COMPANY’s confidentiality obligations to the relevant Third Parties. RENAISSANCE warrants that it will maintain, for the benefit of COMPANY, complete and accurate records of the inventory of all such COMPANY-supplied materialsCOMPANY Material. If requested by COMPANY, DPT RENAISSANCE will provide to COMPANY a monthly [***] report of the ending monthly [***] inventory balance of each type of COMPANY supplied/owned materials Material stored at DPTRENAISSANCE. This reporting [***]. RENAISSANCE will be supplied exclusively use the first-expiring, first-out method of inventory management for COMPANY Material. RENAISSANCE shall not transfer, distribute or release any COMPANY Material to any Third Party without the COMPANY’s prior written consent, except to its Representatives conducting activities on DPT formsbehalf of RENAISSANCE, provided that such any such Representative is bound by written agreements or are otherwise bound to retain and use the COMPANY Material only in the manner permitted under this Agreement and are subject to non-use, confidentiality and intellectual property obligations not less stringent than those provided for in Article IX and Article VII, respectively. RENAISSANCE will only use COMPANY Material as authorized under this Agreement. Risk of loss and damage to COMPANY Material shall remain with [***] (i) in the case of [***], at all times, and (ii) in the case of all other [***] Material, until [***] Material is delivered to RENAISSANCE following which [***] will bear all risk of loss or damage to [***] Material until such [***] Material is returned to [***] or delivered to [***] as part of a completed Product.
Appears in 1 contract
Samples: Manufacturing Agreement (Silverback Therapeutics, Inc.)
Materials Supplied by COMPANY. If COMPANY is to supply The Specification and/or each purchase order shall set forth any material to be supplied by COMPANY to DPT for the manufacture and supply of Products as set forth under this Section, COMPANY shall notify DPT, in writing, specifying which materials it will supplyProduct thereunder. COMPANY shall shall, at COMPANY’s cost and expense, provide DPT with said such materials at COMPANY’s expense along with Certificates of Analysis and MSDS sheets relating to same, at a minimum of thirty (30) days [***] prior to DPT’s scheduled start of production of Product requiring said materials and in sufficient amounts for DPT’s manufacture of Product but not to exceed quantities necessary to support four twelve (412) months of the most recently supplied Forecasted Needs or the minimum order quantity Minimum Order Quantity, whichever is greater. COMPANY COMPANY-supplied material in excess of these amounts shall be either subject to storage fees or returned to COMPANY at COMPANY’s expense. All COMPANY COMPANY- supplied material shall be shipped to DPT freight prepaidDPT’s DDP (Incoterms 2010). In the event COMPANY ships or causes to ship such material freight collect, DPT shall invoice COMPANY for the cost of the freight plus a reasonable administrative fee which invoice shall be paid by COMPANY promptly upon receipt. DPT is hereby authorized by COMPANY to return to COMPANY, at COMPANY’s cost and expense, any portion of COMPANY COMPANY-supplied material for which no future production is planned. COMPANY shall be responsible for the quality of all COMPANY-supplied materials. COMPANY shall be responsible for the payment of all personal property and other taxes incident to the storage of COMPANY-owned supplied material at DPT. For each lot of materials supplied by COMPANY, DPT shall perform the quality control and inspection tests as agreed to in the Specifications unless COMPANY has made arrangements in writing for pre-approved material. DPT shall have the right to reject any pre-approved material which does not meet the Specifications in accordance with paragraph 2.3 below. DPT warrants that that, during the Term, it will maintain, for the benefit of COMPANY, complete and accurate records of the inventory of all such COMPANY-supplied materials. If requested by COMPANY, DPT will provide to COMPANY a monthly report of the ending monthly inventory balance of each COMPANY supplied/owned all COMPANY-supplied materials stored at DPT. This reporting will be supplied exclusively on DPT forms.
Appears in 1 contract
Samples: Supply and Manufacturing Agreement (Evofem Biosciences, Inc.)
Materials Supplied by COMPANY. If COMPANY is to supply any material for manufacture of Products as set forth under this Section, COMPANY shall notify DPT, in writing, specifying which materials it will supply. COMPANY shall provide DPT with said materials at COMPANY’s expense along with Certificates of Analysis and MSDS sheets relating to same, at a minimum of thirty (30) days prior to DPT’s scheduled production of Product requiring said materials and in sufficient amounts for DPT’s manufacture of Product but not to exceed quantities necessary to support four three (43) months of the most recently supplied Forecasted Needs or the minimum order quantity whichever is greater. COMPANY supplied material in excess of these amounts shall be either subject to storage fees or returned to COMPANY. All COMPANY supplied material shall be shipped to DPT freight prepaid. In the event COMPANY ships or causes to ship such material freight collect, DPT shall invoice COMPANY for the cost of the freight plus a reasonable administrative fee which invoice shall be paid promptly upon receipt. DPT is hereby authorized by COMPANY to return any portion of COMPANY supplied material for which no future production is planned. COMPANY shall be responsible for the quality of all COMPANY-supplied materials. COMPANY shall be responsible for the payment of all personal property and other taxes incident to the storage of COMPANY-owned material at DPT. For each lot of materials supplied by COMPANY, DPT shall perform the quality control and inspection tests as agreed to in the Specifications unless COMPANY has made arrangements in writing for pre-approved material. DPT shall have the right to reject any pre-approved material which does not meet the Specifications in accordance with paragraph 2.3 below. DPT warrants that it will maintain, for the benefit of COMPANY, complete and accurate records of the inventory of all such COMPANY-supplied materials. If requested by COMPANY, DPT will provide to COMPANY a monthly report of ending monthly inventory balance of each COMPANY supplied/owned materials stored at DPT. This reporting will be supplied exclusively on DPT forms.
Appears in 1 contract
Samples: Agreement (Barrier Therapeutics Inc)
Materials Supplied by COMPANY. If COMPANY is to supply Each Project Protocol shall set forth any material to be supplied by COMPANY to DPT for the manufacture and supply of Products as set forth under this Section, COMPANY shall notify DPT, in writing, specifying which materials it will supplyProduct thereunder. COMPANY shall shall, at COMPANY’s cost and expense, provide DPT with said such materials at COMPANY’s expense along with Certificates of Analysis and MSDS sheets relating to same, at a minimum of thirty [***] (30[***]) days prior to DPT’s scheduled start of production of Product requiring said materials and in sufficient amounts for DPT’s manufacture of Product but not to exceed quantities necessary to support four [***] (4[***]) months of the most recently supplied Forecasted Needs or the minimum order quantity Minimum Order Quantity, whichever is greater. COMPANY DPT will initiate required testing and release activities for Materials Supplied by the COMPANY, so as to not delay the planned start of any batch manufacturing per the agreed upon production schedule. COMPANY-supplied material in excess of these amounts shall be either subject to storage fees or returned to COMPANY at COMPANY’s expense. All COMPANY COMPANY-supplied material shall be shipped to DPT freight prepaidDDP (Incoterms 2020). In the event COMPANY ships or causes to ship such material freight collect, DPT shall invoice COMPANY for the cost of the freight plus a reasonable administrative fee which invoice shall be paid by COMPANY promptly upon receipt. DPT is hereby authorized by COMPANY to return to COMPANY, at COMPANY’s cost and expense, any portion of COMPANY COMPANY-supplied material for which no future production is planned. COMPANY shall be responsible for the quality of all COMPANY-supplied materials. COMPANY shall be responsible for the payment of all personal property and other taxes incident to the storage of COMPANY-owned supplied material at DPT. For each lot of materials supplied by COMPANY, DPT shall perform the quality control and inspection tests as agreed to in the Specifications unless COMPANY has made arrangements in writing for pre-approved material. DPT shall have the right to reject any pre-approved material which does not meet the Specifications in accordance with paragraph 2.3 below. DPT warrants that that, during the Term, it will maintain, for the benefit of COMPANY, complete and accurate records of the inventory of all such COMPANY-supplied materials. If requested by COMPANY, DPT will provide to COMPANY a monthly report of the ending monthly inventory balance of each COMPANY supplied/owned all COMPANY-supplied materials stored at DPT. This reporting will be supplied exclusively on DPT forms.
Appears in 1 contract
Samples: Supply and Manufacturing Agreement (Arcutis Biotherapeutics, Inc.)