Supply of Materials. (a) It shall be the obligation of DPT to obtain, supply and store all Raw Materials and Components for the manufacture of the Products. DPT shall use commercially reasonable efforts to obtain the best price for all Raw Materials and Components. (b) If for any reason Connetics undertakes to supply any Raw Materials or Components for manufacture of Products, the following requirements shall apply: i. Connetics shall notify DPT, in writing, specifying which materials or components it will supply. ii. Connetics shall provide DPT with said materials at Connetics' 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 * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. necessary to support three (3) months of the most recently supplied Forecasted Needs or the minimum order quantity whichever is greater. Connetics-supplied material in excess of these amounts shall be either subject to storage fees or returned to Connetics. iii. All Connetics supplied material shall be shipped to DPT freight prepaid. If Connetics ships or causes to ship such material freight collect, DPT shall invoice Connetics for the cost of the freight plus a reasonable administrative fee which invoice shall be paid promptly upon receipt. iv. DPT is hereby authorized by Connetics to return any portion of Connetics supplied material for which no future production is planned. v. Connetics shall be responsible for the quality of all Connetics-supplied materials. vi. Connetics shall be responsible for the payment of all personal property and other taxes incident to the storage of Connetics-owned material at DPT. vii. For each lot of materials supplied by Connetics, DPT shall perform the quality control and inspection tests as agreed to in the Specifications and pursuant to DPT's Standard Operating Procedures. DPT shall have the right to reject any pre-approved material which does not meet the Specifications in accordance with SECTION 2.3 below. viii. DPT warrants that it will maintain, for the benefit of Connetics, complete and accurate records of the inventory of all such Connetics-supplied materials. ix. If requested by Connetics, DPT will provide to Connetics a monthly report of ending monthly inventory balance of each Connetics supplied/owned materials stored at DPT. This reporting will be supplied exclusively on DPT forms. (c) DPT shall be responsible for supply, at the expense of Connetics pursuant to subsection (d) below, of all other commodities necessary for the manufacture of Products. (d) Connetics shall provide DPT with Specifications (including art proofs) for packaging and labeling, and DPT shall purchase, at the expense of Connetics, packaging and labeling in accordance with the Specifications. (e) DPT shall invoice Connetics for all Raw Materials and Components supplied by DPT in connection with the Product into which the Raw Materials and Components were converted, as part of the Materials Fee, in accordance with the provisions of SECTION 3.8.
Appears in 2 contracts
Samples: Manufacturing Agreement (Connetics Corp), Manufacturing Agreement (Connetics Corp)
Supply of Materials. 4.1 CUSTOMER will supply API and Inserter System Components (aas described in ATTACHMENT 4.1) It shall be to AMP in adequate quantities to MANUFACTURE each PRODUCT in accordance with the obligation terms and conditions of DPT to obtain, supply and store all Raw Materials and Components for the manufacture of the Productsthis AGREEMENT. DPT shall use commercially reasonable efforts to obtain the best price for all Raw Materials and Components.
(b) If for any reason Connetics undertakes to supply any Raw Materials or Components for manufacture of Products, the following requirements shall apply:
i. Connetics shall notify DPT, in writing, specifying which materials or components it will supply.
ii. Connetics shall provide DPT with said materials at Connetics' expense along with Certificates of Analysis and MSDS sheets relating to same, at a minimum of Within 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 * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. necessary to support three (3) months following receipt of the most recently supplied Forecasted Needs or API from CUSTOMER’s supplier, AMP shall test the minimum order quantity whichever is greater. Connetics-supplied material in excess of these amounts shall be either subject to storage fees or returned to Connetics.
iii. All Connetics supplied material shall be shipped to DPT freight prepaid. If Connetics ships or causes to ship such material freight collect, DPT shall invoice Connetics for the cost of the freight plus a reasonable administrative fee which invoice shall be paid promptly upon receipt.
iv. DPT is hereby authorized by Connetics to return any portion of Connetics supplied material for which no future production is planned.
v. Connetics shall be responsible for the quality of all Connetics-supplied materials.
vi. Connetics shall be responsible for the payment of all personal property and other taxes incident to the storage of Connetics-owned material at DPT.
vii. For each lot of materials supplied by Connetics, DPT shall perform the quality control and inspection tests as agreed to in the Specifications and pursuant to DPT's Standard Operating Procedures. DPT shall have the right to reject any pre-approved material which does not meet the Specifications in accordance with SECTION 2.3 below.
viii. DPT warrants that it will maintain, for the benefit of Connetics, complete and accurate records of the inventory of all such Connetics-supplied materials.
ix. If requested by Connetics, DPT will provide to Connetics a monthly report of ending monthly inventory balance of each Connetics supplied/owned materials stored at DPT. This reporting will be supplied exclusively on DPT forms.
(c) DPT shall be responsible for supply, at the expense of Connetics pursuant to subsection (d) below, of all other commodities necessary for the manufacture of Products.
(d) Connetics shall provide DPT with Specifications (including art proofs) for packaging and labeling, and DPT shall purchase, at the expense of Connetics, packaging and labeling API in accordance with the Specifications.
(e) DPT shall invoice Connetics for all Raw Materials testing procedures specified in the [*] agreed to by the parties and Components supplied by DPT notify CUSTOMER in connection with the Product into which the Raw Materials and Components were converted, as part writing of the Materials Feeresults of any such testing. AMP may not use the shipments of API until CUSTOMER has cleared in writing such material for use. Within fifteen (15) days following receipt of the Inserter System Components from CUSTOMER’s supplier, AMP shall (i) review the certificate of compliance shipped with such Inserter System Components to confirm that such Inserter System Components have been manufactured and tested in accordance with the provisions applicable specifications and (ii) [*] and notify CUSTOMER in writing of SECTION 3.8the results of such actions. Such API and Inserter System Components shall remain the property of * CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. CUSTOMER and shall be used by AMP only for MANUFACTURING of PRODUCT(S).
4.2 AMP shall purchase such MATERIALS, not including API and Inserter System Components, from CUSTOMER approved suppliers in satisfaction of AMP’s requirements for MATERIALS. AMP shall also be responsible to handle, maintain and safely store any API and Inserter System Components located at the FACILITY under proper conditions to preserve quality and prevent damage or other loss. AMP shall only be responsible for any damage or loss to such consigned MATERIALS occurring while located at the Facility as a result of [*]. AMP’s liability under this section 4.2 for damage to consigned MATERIALS shall not exceed [*].
4.3 In the event that CUSTOMER changes any of the MATERIALS, CUSTOMER shall reimburse AMP for the amount of inventory of the MATERIAL (other than the API and Inserter System Components) that was purchased by AMP in accordance with the terms and conditions of this AGREEMENT and that had to be written off as a result of such change, at AMP’s documented cost of purchase from the suppliers plus [*] margin, provided that AMP has used commercially reasonable efforts to return such MATERIAL to its suppliers and was unable to do so for an amount that is less than AMP’s documented cost for such MATERIAL plus the [*] margin. Such inventory shall be returned to CUSTOMER or destroyed, as requested by CUSTOMER, at CUSTOMER’s reasonable expense. If AMP is able to return such MATERIAL for less than AMP’s documented cost for such MATERIAL plus the [*] margin, then AMP shall do so, and CUSTOMER shall reimburse AMP for the difference in cost from the original purchase to the actual credit received for the return of such MATERIAL plus [*] margin.
4.4 In the event that MATERIALS required to MANUFACTURE the PRODUCTS are in short supply, AMP shall notify CUSTOMER in writing of such circumstances as soon as possible, including without limitation the underlying reasons for such shortage, proposed remedial measures, and the date such inability is expected to end.
Appears in 2 contracts
Samples: Commercial Contract Manufacturing Agreement (Alimera Sciences Inc), Commercial Contract Manufacturing Agreement (Alimera Sciences Inc)
Supply of Materials. (a) It LONZA shall supply, at its expense, all Materials necessary to 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 the obligation delivered a reasonably sufficient amount of DPT to obtain, supply and store all Raw Materials and Components for the manufacture each of the Products. DPT shall use commercially reasonable efforts applicable PCYC Materials for each Product to obtain the best price for all Raw Materials and Components.
(b) If for any reason Connetics undertakes to supply any Raw Materials or Components for manufacture of Products, the following requirements shall apply:
i. Connetics shall notify DPT, in writing, specifying which materials or components it will supply.
ii. Connetics shall provide DPT with said materials at Connetics' 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 * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect be Manufactured hereunder to the omitted portions. necessary to support three (3) months applicable Facility sufficiently in advance of the most recently supplied Forecasted Needs or time that such PCYC Materials will be required for use in the minimum order quantity whichever is greaterManufacture of such Product under the applicable Purchase Order. Connetics-supplied material in excess of these Such required advance times and amounts shall be either subject to set forth in the applicable Product Appendix, as well as any applicable storage fees or returned to Connetics.
iiirequirements for such PCYC Materials. All Connetics supplied material shall be shipped to DPT freight prepaid. If Connetics ships or causes to ship such material freight collect, DPT shall invoice Connetics for the cost Upon receipt of the freight plus a reasonable administrative fee which invoice PCYC Materials as set forth above, LONZA shall be paid promptly upon receipt.
iv. DPT is hereby authorized by Connetics to return any portion review the accompanying certificate(s) of Connetics supplied material analysis and test the PCYC Materials for which no future production is planned.
v. Connetics shall be responsible for the quality of all Connetics-supplied materials.
vi. Connetics shall be responsible for the payment of all personal property and other taxes incident to the storage of Connetics-owned material at DPT.
vii. For each lot of materials supplied by Connetics, DPT shall perform the quality control and inspection tests as agreed to in the Specifications and pursuant to DPT's Standard Operating Procedures. DPT shall have the right to reject any pre-approved material which does not meet the Specifications in accordance with SECTION 2.3 below.
viii. DPT warrants that it will maintain, for the benefit of Connetics, complete and accurate records of the inventory of all such Connetics-supplied materials.
ix. If requested by Connetics, DPT will provide to Connetics a monthly report of ending monthly inventory balance of each Connetics supplied/owned materials stored at DPT. This reporting will be supplied exclusively on DPT forms.
(c) DPT shall be responsible for supply, at the expense of Connetics pursuant to subsection (d) below, of all other commodities necessary for the manufacture of Products.
(d) Connetics shall provide DPT with Specifications (including art proofs) for packaging and labeling, and DPT shall purchase, at the expense of Connetics, packaging and labeling in accordance conformance with the Specifications.
(e) DPT shall invoice Connetics for all Raw Materials and Components supplied by DPT in connection with the Product into which the Raw Materials and Components were converted, as part of the Materials Feeapplicable Identification Testing Standards, in accordance with the provisions 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 time upon mutual written agreement of SECTION 3.8PCYC and LONZA. Within [ *** ] of receipt of the PCYC Materials described in Section 3.2.2, or such other period as may be specified in the applicable Product Appendix, LONZA shall determine if such PCYC Materials meet the applicable Identification Testing Standards. If LONZA determines that such PCYC Materials meet the Identification Testing Standards, then such PCYC Materials shall be used by LONZA in performing its Manufacturing obligations under this Agreement. If 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 PCYC 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, 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 all PCYC Materials at all times. If PCYC fails to deliver to LONZA the PCYC Materials necessary to fulfill a 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 fulfill such request. To the extent that such rescheduling directly results in the plant capacity reserved for the fulfillment of such Purchase Order being unutilized, PCYC shall reimburse LONZA for such unutilized capacity in accordance with Section 3.5.2. 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 deemed 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) It XXXXX shall be the obligation of DPT to obtain, supply and store all Raw Materials and Components for the manufacture of the Products. DPT shall use commercially reasonable efforts to obtain the best price for all Raw Materials and Components.
(b) If for any reason Connetics undertakes to supply any Raw Materials or Components for manufacture of Products, the following requirements shall apply:
i. Connetics shall notify DPT, in writing, specifying which materials or components it will supply.
ii. Connetics shall provide DPT with said materials at Connetics' 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 * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. necessary to support three (3) months of the most recently supplied Forecasted Needs or the minimum order quantity whichever is greater. Connetics-supplied material in excess of these amounts shall be either subject to storage fees or returned to Connetics.
iii. All Connetics supplied material shall be shipped to DPT freight prepaid. If Connetics ships or causes to ship such material freight collect, DPT shall invoice Connetics for the cost of the freight plus a reasonable administrative fee which invoice shall be paid promptly upon receipt.
iv. DPT is hereby authorized by Connetics to return any portion of Connetics supplied material for which no future production is planned.
v. Connetics shall be responsible for the quality of all Connetics-supplied materials.
vi. Connetics shall be responsible for the payment of all personal property and other taxes incident to the storage of Connetics-owned material at DPT.
vii. For each lot of materials supplied by Connetics, DPT shall perform the quality control and inspection tests as agreed to in the Specifications and pursuant to DPT's Standard Operating Procedures. DPT shall have the right to reject any pre-approved material which does not meet the Specifications in accordance with SECTION 2.3 below.
viii. DPT warrants that it will maintain, for the benefit of Connetics, complete and accurate records of the inventory of all such Connetics-supplied materials.
ix. If requested by Connetics, DPT will provide to Connetics a monthly report of ending monthly inventory balance of each Connetics supplied/owned materials stored at DPT. This reporting will be supplied exclusively on DPT forms.
(c) DPT shall be responsible for supply, at its expense, all Materials necessary to Manufacture each Product other than the expense of Connetics pursuant to subsection (d) below, of all other commodities necessary for the manufacture of Products.
(d) Connetics PCYC Materials. PCYC shall provide DPT with Specifications (including art proofs) for packaging and labeling, and DPT shall purchasesupply, 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 expense applicable PCYC Materials for each Product to be Manufactured hereunder to the applicable Facility sufficiently in advance of Conneticsthe date of delivery set forth in the applicable Purchase Order such that XXXXX can fill such Purchase Orders, packaging which required advance time, as well as any storage requirements for such PCYC Materials, shall be set forth in the applicable Product Appendix. Upon receipt of the PCYC Materials as set forth above, XXXXX shall review the accompanying certificate(s) of analysis and labeling in accordance test the PCYC Materials for conformance with the Specifications.
(e) DPT shall invoice Connetics for all Raw Materials and Components supplied by DPT in connection with the Product into which the Raw Materials and Components were converted, as part of the Materials FeeIdentification Testing Standards, in accordance with the provisions 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 time upon mutual written agreement of SECTION 3.8.PCYC and XXXXX. Within [ *** ] of receipt of the PCYC Materials described in Section 3.3.1, or such other period as may be specified in the applicable Product Appendix, XXXXX shall determine if such PCYC Materials meet the applicable Identification Testing Standards. If XXXXX determines that such PCYC Materials meet the Identification Testing Standards, then such PCYC Materials shall be used by XXXXX in performing its Manufacturing obligations under this Agreement. If 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 PCYC 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, 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 all PCYC Materials at all times. Forecasts. [ *** ]
Appears in 1 contract
Samples: Supply Agreement (Pharmacyclics Inc)
Supply of Materials. (a) It shall be the obligation of DPT to obtain, supply and store all Raw Materials and Components for the manufacture of the Products. DPT shall use commercially reasonable efforts to obtain the best price for all Raw Materials and Components.
(b) If for any reason Connetics undertakes to supply any Raw Materials or Components for manufacture of Products, the following requirements shall apply:
i. Connetics shall notify DPT, in writing, specifying which materials or components it will supply.
ii. Connetics shall provide DPT with said materials at Connetics' 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 * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. necessary to support three (3) months of the most recently supplied Forecasted Needs or the minimum order quantity whichever is greater. Connetics-supplied material in excess of these amounts shall be either subject to storage fees or returned to Connetics.
iii. All Connetics supplied material shall be shipped to DPT freight prepaid. If Connetics ships or causes to ship such --------------- ** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. material freight collect, DPT shall invoice Connetics for the cost of the freight plus a reasonable administrative fee which invoice shall be paid promptly upon receipt.
iv. DPT is hereby authorized by Connetics to return any portion of Connetics supplied material for which no future production is planned.
v. Connetics shall be responsible for the quality of all Connetics-supplied materials.
vi. Connetics shall be responsible for the payment of all personal property and other taxes incident to the storage of Connetics-owned material at DPT.
vii. For each lot of materials supplied by Connetics, DPT shall perform the quality control and inspection tests as agreed to in the Specifications and pursuant to DPT's Standard Operating Procedures. DPT shall have the right to reject any pre-approved material which does not meet the Specifications in accordance with SECTION 2.3 below.
viii. DPT warrants that it will maintain, for the benefit of Connetics, complete and accurate records of the inventory of all such Connetics-supplied materials.
ix. If requested by Connetics, DPT will provide to Connetics a monthly report of ending monthly inventory balance of each Connetics supplied/owned materials stored at DPT. This reporting will be supplied exclusively on DPT forms.
(c) DPT shall be responsible for supply, at the expense of Connetics pursuant to subsection (d) below, of all other commodities necessary for the manufacture of Products.
(d) Connetics shall provide DPT with Specifications (including art proofs) for packaging and labeling, and DPT shall purchase, at the expense of Connetics, packaging and labeling in accordance with the Specifications.
(e) DPT shall invoice Connetics for all Raw Materials and Components supplied by DPT in connection with the Product into which the Raw Materials and Components were converted, as part of the Materials Fee, in accordance with the provisions of SECTION 3.8.
Appears in 1 contract
Supply of Materials. A. TXMD shall supply to QPharma for Processing, at TXMD’s cost, all TXMD-supplied Materials set forth on Attachment C, if any, in quantities sufficient to meet TXMD’s requirements for Product. TXMD shall deliver such items and associated certificates of analysis to the Facility no later than [***] (a[***]) It days before the Processing Date. TXMD’s failure to fulfill the foregoing obligations in this Section 3.2 shall not by itself give rise to a cause of action in QPharma or a right by it to terminate this Agreement. However, QPharma shall not be the obligation of DPT held liable for a delayed Processing Date related to obtain, supply and store all Raw TXMD’s own delay in delivering TXMD supplied Materials and Components for the manufacture of the Products. DPT shall use commercially reasonable efforts to obtain the best price for all Raw Materials and Components.
(b) If for any reason Connetics undertakes to supply any Raw Materials or Components for manufacture of Products, the following requirements shall apply:
i. Connetics shall notify DPT, in writing, specifying which materials or components it will supply.
ii. Connetics shall provide DPT with said materials at Connetics' 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 * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect associated certificates to the omitted portionsFacility. necessary to support three (3) months of the most recently supplied Forecasted Needs or the minimum order quantity whichever is greater. Connetics-supplied material in excess of these amounts shall be either subject to storage fees or returned to Connetics.
iii. All Connetics supplied material shall be shipped to DPT freight prepaid. If Connetics ships or causes to ship such material freight collect, DPT shall invoice Connetics for the cost of the freight plus a reasonable administrative fee which invoice shall be paid promptly upon receipt.
iv. DPT is hereby authorized by Connetics to return any portion of Connetics supplied material for which no future production is planned.
v. Connetics TXMD shall be responsible at its expense for the quality securing any necessary DEA, export or import, similar clearances, permits or certifications required in respect of such supply. QPharma shall use such items solely for Processing. Prior to delivery of any such items, TXMD shall provide to QPharma a copy of all Conneticsassociated material safety data sheets, safe handling instructions and health and environmental information and any Regulatory certifications or authorizations that may be required under Applicable Laws with respect thereto, and shall promptly provide any updates thereto.
B. Following receipt of TXMD-supplied materials.
viMaterials, QPharma shall inspect, test and release such items employing such measures as are set forth in the Specifications. Connetics shall be responsible for QPharma will receive, handle, store and use all TXMD-supplied Materials in compliance with all Applicable Laws and labeled storage requirements, or lacking labeled storage requirement, the payment written instructions of all personal property and other taxes incident to the storage of Connetics-owned material at DPT.
vii. For each lot of materials supplied by ConneticsTXMD, DPT shall perform the quality control and inspection tests as agreed to by QPharma, such agreement not to be unreasonably withheld. In the event that QPharma detects a nonconformity with Specifications, QPharma shall give TXMD prompt notice of such nonconformity. QPharma shall not be liable for any defects in TXMD-supplied Materials, or in Product resulting from defective TXMD-supplied Materials, unless QPharma failed to properly perform the Specifications and pursuant to DPT's Standard Operating Proceduresforegoing obligations. DPT QPharma shall have the right to reject any prefollow TXMD’s reasonable written instructions in respect of return or disposal of defective TXMD-approved material which does not meet the Specifications in accordance with SECTION 2.3 belowsupplied Materials, at TXMD’s cost.
viii. DPT warrants that it will maintain, for the benefit of Connetics, complete and accurate records of the inventory of all such ConneticsC. TXMD shall retain title to TXMD-supplied materials.
ix. If requested by ConneticsMaterials at all times and shall bear the risk of loss thereof, DPT will provide except for losses to Connetics a monthly report the extent due to the negligent acts or omissions of ending monthly inventory balance QPharma or QPharma’s failure to follow storage and handling requirements or mutually agreed to written instructions of each Connetics supplied/owned materials stored at DPT. This reporting will be supplied exclusively on DPT forms.
(c) DPT shall be responsible for supply, at the expense of Connetics pursuant to subsection (d) below, of all other commodities necessary for the manufacture of Products.
(d) Connetics shall provide DPT with Specifications (including art proofs) for packaging and labeling, and DPT shall purchase, at the expense of Connetics, packaging and labeling in accordance with the Specifications.
(e) DPT shall invoice Connetics for all Raw Materials and Components supplied by DPT in connection with the Product into which the Raw Materials and Components were converted, as part of the Materials FeeTXMD, in accordance with the provisions of SECTION 3.8each case, subject to Article 14.
Appears in 1 contract
Supply of Materials. (a) It DOTTIKON shall be the obligation of DPT to obtain, supply and store all Raw Materials and Components for the manufacture of the Products. DPT shall use commercially reasonable efforts to obtain the best price for all Raw Materials and Components.
(b) If for any reason Connetics undertakes to supply any Raw Materials or Components for manufacture of Products, the following requirements shall apply:
i. Connetics shall notify DPT, in writing, specifying which materials or components it will supply.
ii. Connetics shall provide DPT with said materials at Connetics' 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 * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. necessary to support three (3) months of the most recently supplied Forecasted Needs or the minimum order quantity whichever is greater. Connetics-supplied material in excess of these amounts shall be either subject to storage fees or returned to Connetics.
iii. All Connetics supplied material shall be shipped to DPT freight prepaid. If Connetics ships or causes to ship such material freight collect, DPT shall invoice Connetics for the cost of the freight plus a reasonable administrative fee which invoice shall be paid promptly upon receipt.
iv. DPT is hereby authorized by Connetics to return any portion of Connetics supplied material for which no future production is planned.
v. Connetics shall be responsible for the quality of all Connetics-supplied materials.
vi. Connetics shall be responsible for the payment of all personal property and other taxes incident to the storage of Connetics-owned material at DPT.
vii. For each lot of materials supplied by Connetics, DPT shall perform the quality control and inspection tests as agreed to in the Specifications and pursuant to DPT's Standard Operating Procedures. DPT shall have the right to reject any pre-approved material which does not meet the Specifications in accordance with SECTION 2.3 below.
viii. DPT warrants that it will maintain, for the benefit of Connetics, complete and accurate records of the inventory of all such Connetics-supplied materials.
ix. If requested by Connetics, DPT will provide to Connetics a monthly report of ending monthly inventory balance of each Connetics supplied/owned materials stored at DPT. This reporting will be supplied exclusively on DPT forms.
(c) DPT shall be responsible for supply, at its expense, all Materials necessary to Manufacture each Product other than the expense of Connetics pursuant to subsection (d) below, of all other commodities necessary for the manufacture of Products.
(d) Connetics PCYC Materials. PCYC shall provide DPT with Specifications (including art proofs) for packaging and labeling, and DPT shall purchasesupply, 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 expense applicable PCYC Materials for each Product to be Manufactured hereunder to the applicable Facility sufficiently in advance of Conneticsthe date of delivery set forth in the applicable Purchase Order such that DOTTIKON can fill such Purchase Orders, packaging which required advance time, as well as any storage requirements for such PCYC Materials, shall be set forth in the applicable Product Appendix. Upon receipt of the PCYC Materials as set forth above, DOTTIKON shall review the accompanying certificate(s) of analysis and labeling in accordance test the PCYC Materials for conformance with the Specifications.
(e) DPT shall invoice Connetics for all Raw Materials and Components supplied by DPT in connection with the Product into which the Raw Materials and Components were converted, as part of the Materials FeeIdentification Testing Standards, in accordance with the provisions 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 time upon mutual written agreement of SECTION 3.8PCYC and DOTTIKON. Within [ *** ] of receipt of the PCYC Materials described in Section 3.3.1, or such other period as may be specified in the applicable Product Appendix, DOTTIKON shall determine if such PCYC Materials meet the applicable Identification Testing Standards. If DOTTIKON determines that such PCYC Materials meet the Identification Testing Standards, then such PCYC Materials shall be used by DOTTIKON in performing its Manufacturing obligations under this Agreement. If 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 PCYC 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, 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 all PCYC Materials at all times.
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Samples: Supply Agreement (Pharmacyclics Inc)