Supply. (a) Obligations of Russell and Manufacturer (i) Russell agrees xx xxxxhase Yarn from Manufacturer in mutually agreed upon counts for Russell's use in manufacturing apparel prxxxxxx. Xubject to the terms and conditions of this Agreement, during each Year of the Term of this Agreement, Manufacturer agrees to supply to Russell the Annual Minimum and Russell agxxxx xx purchase from Manufactuxxx xx least the Annual Minimum. (ii) Russell shall have the right to purchase Additional Capacity within the terms outlined in Forecasts and Orders (as specified in Paragraph 2(e) herein). The price for Additional Capacity will be determined in accordance with Schedule C. The terms and conditions for the purchase of the Additional Capacity shall be in accordance with the terms of this Agreement. (iii) If during any month Russell fails to timely notify Manufacturxx xx xts intent to utilize all or a portion of the Additional Capacity, or if Russell notifies Manufacturer that it intxxxx xx use a portion of the Additional Capacity, Manufacturer shall be free to sell any unused portion of the Additional Capacity to a third party. Manufacturer may sell any capacity of Yarn in excess of the Annual Minimum and the Additional Capacity to a third party. (iv) If Russell determines that it will not purchase the monthly pro rata share of the Annual Minimum during a month, Russell shall deliver a Shortfall Notice to Xxxxfacturer as soon as reasonably practicable to enable Manufacturer to sell such Anticipated Shortfall to a third party or parties. Upon receipt of the Shortfall Notice, Manufacturer shall use its best efforts to secure orders from third parties to utilize such Anticipated Shortfall; provided, however, that if Manufacturer is unable to secure orders from third parties for all of the Anticipated Shortfall within thirty (30) days of receipt of a Shortfall Notice, it shall deliver a Reimbursement Notice to Russell. The Reimbursement Notice shall ixxxxxx a calculation of the Idle Capacity Payment in accordance with the sample formula contained in Paragraph 1(e). If Manufacturer sells the Anticipated Shortfall to a third party, the Idle Capacity Payment will be adjusted for the difference between the outside selling price conversion and the agreed upon conversion by Russell. If Manufacturer's sales of Anticxxxxxx Shortfall exceed the amount which would have constituted the Price if Russell had purchased the Anticipated Shoxxxxxx, such excess will be used by Manufacturer as an offset to future Idle Capacity Payments due from Russell. (v) Russell shall remit the Idle Caxxxxxx Payment to Manufacturer within thirty (30) days from the date of receipt of the Reimbursement Notice. (vi) If, prior to or during a month, Manufacturer determines that there will be a Manufacturer's Shortfall, Manufacturer shall provide prompt written notice to Russell. Within ten (10) days of the date Xxxxxxcturer provides notice to Russell of a Manufacturer's Shortfall, Frxxxxxx will provide written notice to Russell of either: (A) its agreement to sxxxxx xhe Manufacturer's Shortfall in accordance with the terms and conditions of this Agreement or (B) its inability to supply the Manufacturer's Shortfall in accordance with the terms and conditions of this Agreement. In the event of a Manufacturer's Shortfall and Frontier's notice of inability to supply Manufacturer's Shortfall or its failure to supply Manufacturer's Shortfall in accordance with the terms of this Agreement, Russell shall have the right to purchase xx xxxxnt of yarn equal to the Manufacturer's Shortfall from a third party. In this event, Russell's obligation to purchase the Annual Xxxxxxm shall be reduced by the amount of the Manufacturer's Shortfall and Manufacturer shall pay to Russell the Manufacturer's Shortfall Payment xxxhin thirty (30) days of receipt of written notice from Russell.
Appears in 1 contract
Samples: Supply Agreement (Russell Corp)
Supply. (a) Obligations 6.1 During the term of Russell this Agreement, DOBFAR shall manufacture, label and Manufacturer
(i) Russell agrees xx xxxxhase Yarn from Manufacturer in mutually agreed upon counts package, ship and deliver the Product for Russell's use in manufacturing apparel prxxxxxx. Xubject to SAGENT on the terms and conditions of this Agreement, during each Year of the Term of this Agreement, Manufacturer agrees to supply to Russell the Annual Minimum and Russell agxxxx xx purchase from Manufactuxxx xx least the Annual Minimum.
(ii) Russell shall have the right to purchase Additional Capacity within the terms outlined in Forecasts and Orders (as specified in Paragraph 2(e) herein)this Agreement and in compliance with all requirements of applicable laws, rules and regulations, and all other requirements of any applicable cGMP and Specifications. The price for Additional Capacity will be determined in accordance with Schedule C. The terms and conditions for the purchase of the Additional Capacity Product shall be manufactured by DOBFAR at the applicable Manufacturing Facility in accordance with the terms of this Agreement and the Quality Agreement. Except as set forth in Section 7.1, SAGENT shall not be required to order any fixed minimum quantity of Product or any quantity of Product for which it does not actually have a need, notwithstanding any forecast or prior course of dealing.
(iii) If 6.2 During the term of this Agreement, DOBFAR shall be solely responsible for arranging for an FDA-approved third party to manufacture and supply the API necessary to manufacture the Product in accordance with all requirements of applicable laws, rules and regulations, and all other requirements of any applicable cGMP and Specifications and in sufficient quantities to meet SAGENT’s forecasted needs for the Product; provided that DOBFAR shall give written notice to SAGENT in advance of retaining any such third party API supplier. With respect to any third party API supplier that DOBFAR desires to use, DOBFAR shall ensure that such third party API supplier makes its facilities and records relating to the manufacture of the API available for inspection by SAGENT as SAGENT requests from time to time. In the event that during any month Russell fails to timely notify Manufacturxx xx xts intent to utilize all such inspection, SAGENT identifies any instances of noncompliance with the requirements of applicable laws, rules and regulations, applicable cGMP or the Specifications, then DOBFAR shall promptly provide a portion of the Additional Capacitywritten plan for correcting such deficiencies (including a proposed timetable for implementing such corrections) and shall ensure that such deficiencies are corrected, at DOBFAR’s or if Russell notifies Manufacturer that it intxxxx xx use a portion of the Additional Capacitysuch third party API supplier’s sole expense, Manufacturer shall be free to sell any unused portion of the Additional Capacity to a third party. Manufacturer may sell any capacity of Yarn in excess of the Annual Minimum and the Additional Capacity to a third party.
(iv) If Russell determines that it will not purchase the monthly pro rata share of the Annual Minimum during a month, Russell shall deliver a Shortfall Notice to Xxxxfacturer as soon as reasonably practicable practicable. If not corrected to enable Manufacturer to sell such Anticipated Shortfall to a SAGENT’s satisfaction (or if the third party or partiesAPI supplier does not make its facility and records available for inspection by SAGENT), then DOBFAR shall be required to secure a different third party API supplier, and to immediately cease using the noncompliant supplier. Upon receipt Subject to Section 6.3, DOBFAR shall be solely responsible for ensuring that the API so supplied to it is of sufficient quality and meets other relevant standards in order for it to be utilized by DOBFAR in the manufacture of the Shortfall Notice, Manufacturer shall use its best efforts to secure orders from third parties to utilize such Anticipated Shortfall; provided, however, that if Manufacturer is unable to secure orders from third parties for all of the Anticipated Shortfall within thirty (30) days of receipt of a Shortfall Notice, it shall deliver a Reimbursement Notice to Russell. The Reimbursement Notice shall ixxxxxx a calculation of the Idle Capacity Payment Product in accordance with the sample formula contained in Paragraph 1(e). If Manufacturer sells the Anticipated Shortfall to a third party, the Idle Capacity Payment will be adjusted for the difference between the outside selling price conversion and the agreed upon conversion by Russell. If Manufacturer's sales of Anticxxxxxx Shortfall exceed the amount which would have constituted the Price if Russell had purchased the Anticipated Shoxxxxxx, such excess will be used by Manufacturer as an offset to future Idle Capacity Payments due from RussellSection 6.1.
(v) Russell shall remit the Idle Caxxxxxx Payment to Manufacturer within thirty (30) days from the date of receipt of the Reimbursement Notice.
(vi) If, prior to or during a month, Manufacturer determines that there will be a Manufacturer's Shortfall, Manufacturer shall provide prompt written notice to Russell. Within ten (10) days of the date Xxxxxxcturer provides notice to Russell of a Manufacturer's Shortfall, Frxxxxxx will provide written notice to Russell of either: (A) its agreement to sxxxxx xhe Manufacturer's Shortfall in accordance with the terms and conditions of this Agreement or (B) its inability to supply the Manufacturer's Shortfall in accordance with the terms and conditions of this Agreement. In the event of a Manufacturer's Shortfall and Frontier's notice of inability to supply Manufacturer's Shortfall or its failure to supply Manufacturer's Shortfall in accordance with the terms of this Agreement, Russell shall have the right to purchase xx xxxxnt of yarn equal to the Manufacturer's Shortfall from a third party. In this event, Russell's obligation to purchase the Annual Xxxxxxm shall be reduced by the amount of the Manufacturer's Shortfall and Manufacturer shall pay to Russell the Manufacturer's Shortfall Payment xxxhin thirty (30) days of receipt of written notice from Russell.
Appears in 1 contract
Samples: Manufacturing Agreement
Supply. (a) Obligations 2.1 Requests for design will be placed as described in Exhibit B, and orders for Oligonucleotide synthesis will be placed by Buyer according to process described in Exhibit B. All terms and conditions of Russell and Manufacturer
(i) Russell agrees xx xxxxhase Yarn from Manufacturer in mutually agreed upon counts for Russell's use in manufacturing apparel prxxxxxxthis Agreement shall supersede any terms or conditions of said Purchase Order, which modify or are otherwise CONFIDENTIAL TREATMENT REQUESTED UNDER C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. Xubject to [****] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION. inconsistent with the terms and conditions of this Agreement, during each Year of the Term of this Agreement, Manufacturer agrees to supply to Russell the Annual Minimum and Russell agxxxx xx purchase from Manufactuxxx xx least the Annual Minimum.
(ii) Russell shall have the right to purchase Additional Capacity within the terms outlined in Forecasts and Orders (as specified in Paragraph 2(e) herein). The price for Additional Capacity will be determined in accordance with Schedule C. The unless other terms and conditions for the purchase of the Additional Capacity shall are signed by both Parties. All Products will be supplied by SIGMA in accordance with the terms of this AgreementSpecifications in Exhibit A.
2.2 All Product supplied by SIGMA shall be supplied F.O.B. The Woodlands, Texas.
(iii) If during 2.3 SIGMA shall ship Products in a commercially reasonable manner in accordance with Buyer’s reasonable instructions.
2.4 SIGMA shall accept and adhere to the requirements of the Vendor Quality Agreement set out in Exhibit D.
2.5 In the event that any month Russell fails to timely notify Manufacturxx xx xts intent to utilize all or a portion of the Additional Capacityshipment of Products received by Buyer fails to conform to the Specifications, or if Russell notifies Manufacturer that it intxxxx xx use a portion of Buyer may reject the Additional Capacity, Manufacturer shall be free non-conforming Products shipment by giving written notice to sell any unused portion of the Additional Capacity to a third party. Manufacturer may sell any capacity of Yarn in excess of the Annual Minimum and the Additional Capacity to a third party.
(iv) If Russell determines that it will not purchase the monthly pro rata share of the Annual Minimum during a month, Russell shall deliver a Shortfall Notice to Xxxxfacturer as soon as reasonably practicable to enable Manufacturer to sell such Anticipated Shortfall to a third party or parties. Upon receipt of the Shortfall Notice, Manufacturer shall use its best efforts to secure orders from third parties to utilize such Anticipated Shortfall; provided, however, that if Manufacturer is unable to secure orders from third parties for all of the Anticipated Shortfall SIGMA within thirty (30) days of Buyer’s receipt of the Products, which notice shall specify the manner in which the Products fail to meet the Specifications. In the event a Shortfall Notice, it shall deliver a Reimbursement Notice to Russell. The Reimbursement Notice shall ixxxxxx a calculation Product defect could not have been ascertained by Buyer upon reasonable inspection of the Idle Capacity Payment in accordance with Product and analysis thereof, then the sample formula contained in Paragraph 1(e). If Manufacturer sells the Anticipated Shortfall to a third party, the Idle Capacity Payment will be adjusted for the difference between the outside selling price conversion and the agreed upon conversion by Russell. If Manufacturer's sales of Anticxxxxxx Shortfall exceed the amount which would have constituted the Price if Russell had purchased the Anticipated Shoxxxxxx, such excess will be used by Manufacturer as an offset to future Idle Capacity Payments due from Russell.
(v) Russell shall remit the Idle Caxxxxxx Payment to Manufacturer within thirty (30) days day time period referred to herein shall not apply provided that (i) Buyer notifies SIGMA promptly upon having reason to know of such Product defect (but in any event no later than three (3) months from the date of receipt of delivery) and (ii) the Reimbursement Noticelimitation on remedy and liability set out in Section 2.7 shall apply with respect thereto.
(vi) If, prior to or during a month, Manufacturer determines that there will be a Manufacturer's Shortfall, Manufacturer shall provide prompt written notice to Russell. Within ten (10) days of the date Xxxxxxcturer provides notice to Russell of a Manufacturer's Shortfall, Frxxxxxx will provide written notice to Russell of either: (A) its agreement to sxxxxx xhe Manufacturer's Shortfall in accordance with the terms and conditions of this Agreement or (B) its inability to supply the Manufacturer's Shortfall in accordance with the terms and conditions of this Agreement. 2.6 In the event SIGMA does not agree that any such Product failed to meet the Specifications (per Section 2.1) and SIGMA and Buyer cannot reach agreement with respect to such Product, SIGMA will submit the question of a Manufacturer's Shortfall whether the Product failed to meet the Specifications to an independent laboratory selected by SIGMA and Frontier's approved by Buyer for determination. The findings of such laboratory shall be binding upon SIGMA and Buyer and the cost of such determination shall be paid by the party in error.
2.7 Subject to Sections 2.4 and 2.5, SIGMA shall replace any Product not conforming to the Specifications forthwith at its expense within 15 business days of receiving Buyer’s written notice of inability non-conformity. Buyer shall return, at SIGMA’s expense, the nonaccepted Products to supply Manufacturer's Shortfall or SIGMA.
2.8 Except as provided for under Section 4.5 regarding SIGMA’s indemnification obligations for third party claims, the remedies described in Section 2.5 and 2.6 shall be Buyer’s sole remedy and SIGMA’s only liability to Buyer hereunder with respect thereto.
2.9 SIGMA warrants that all federal environmental and safety requirements are being and will be followed at its failure to supply Manufacturer's Shortfall in accordance with the terms of this Agreement, Russell facilities. Buyer shall have the right to purchase xx xxxxnt inspect at reasonable times during normal business hours, and on reasonable prior notice, the operations and facilities of yarn equal SIGMA wherein Products are manufactured to evaluate compliance with applicable environmental and occupational health and safety laws and regulations. CONFIDENTIAL TREATMENT REQUESTED UNDER C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. [****] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION.
2.10 SIGMA shall notify Buyer of significant incidents relating to production of the Product, including but not limited to the Manufacturer's Shortfall following (i) fatalities and/or significant injuries or occupations illnesses; (ii) incidents resulting in property damage of [****] or more; (iii) environmental releases reportable to regulatory agencies; (iv) regulatory agency inspections alleging non-compliance; and (v) request for information, notices of violations or other communication from a third party. In this eventgovernmental agency relating to environmental or occupational health and safety compliance.
2.11 At Buyer’s request, Russell's obligation SIGMA shall provide copies of all relevant environmental licenses and permits pertaining to purchase the Annual Xxxxxxm its operation and shall be reduced notify Buyer of any change in status.
2.12 At Buyer’s request, SIGMA will provide Buyer with copies of all applicable insurance certificates.
2.13 SIGMA agrees that it will conduct all necessary testing of Product as required by the amount of the Manufacturer's Shortfall any and Manufacturer shall pay to Russell the Manufacturer's Shortfall Payment xxxhin thirty (30) days of receipt of written notice from Russellall applicable governmental regulations.
Appears in 1 contract
Supply. (a) Obligations QuickLogic reserves the right to obtain an alternative source ("Second Source"), for up to a maximum of Russell [*] of its total number of wafers from * An asterisk indicates confidential material that has been omitted from this document and Manufacturer
filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Confidential Treatment has been requested with respect to the omitted portions. all its foundry sources excluding sources as stated in paragraph 2(a) in any one year. In the event that TSMC fails to meet the TSMC Committed Capacity or QuickLogic's market requirements defined as (i) Russell agrees xx xxxxhase Yarn from Manufacturer in mutually agreed upon counts for Russell's use in manufacturing apparel prxxxxxx. Xubject to the terms and conditions of this Agreementmarket capacity, during each Year of the Term of this Agreement, Manufacturer agrees to supply to Russell the Annual Minimum and Russell agxxxx xx purchase from Manufactuxxx xx least the Annual Minimum.
(ii) Russell Product quality as per Exhibit E and F or (iii) average Product yields as per TSMC's predicted yield model for any Product, then QuickLogic shall have the right to purchase Additional Capacity within Second Source the terms outlined in Forecasts and Orders (Products without regard to quantity limitations until such time as specified in Paragraph 2(e) herein). The price for Additional Capacity will be determined in accordance with Schedule C. The terms and conditions for the purchase of the Additional Capacity shall be in accordance with the terms of this AgreementTSMC can supply such committed capacity or such QuickLogic market requirements.
(iiib) If during TSMC is aware of any month Russell fails reason that will cause a delay in meeting its commitment to timely notify Manufacturxx xx xts intent supply Products to utilize all or a portion of the Additional CapacityQuickLogic, or if Russell notifies Manufacturer that it intxxxx xx use a portion of the Additional Capacity, Manufacturer TSMC shall be free required to sell any unused portion of the Additional Capacity to a third party. Manufacturer may sell any capacity of Yarn immediately notify QuickLogic in excess of the Annual Minimum and the Additional Capacity to a third partywriting.
(ivc) If Russell determines that it will not purchase TSMC fails to deliver Products ordered by QuickLogic within the monthly pro rata share TSMC Committed Capacity, including a failure to deliver due to low Product or process yields, and such failure to deliver results in a failure by QuickLogic to take delivery of the Annual Minimum during Take or Pay Capacity, then QuickLogic shall not be liable for the Take or Pay Fee for any shortfall in Products resulting from TSMC's failure to deliver.
(d) If TSMC fails to meet its delivery dates on two or more successive deliveries by more than fourteen (14) days, a month, Russell shall deliver a Shortfall Notice to Xxxxfacturer as soon as reasonably practicable to enable Manufacturer to sell such Anticipated Shortfall to a third party or parties. Upon receipt senior officer of QuickLogic will discuss the cause of the Shortfall Noticedelay with the President of TSMC, Manufacturer USA and discuss the means to correct the failures and TSMC shall take specific steps to prevent similar events in the future, thus ensuring that TSMC meets its commitments. If the corrective action has not remedied the delays in delivery within sixty (60) calendar days, the president of QuickLogic shall call the president of TSMC, Ltd., Taiwan and TSMC shall use its best efforts to secure orders from third parties remedy the failure to utilize meet its commitments in the shortest possible time. Failure of TSMC to use its best efforts at such Anticipated Shortfall; provided, however, that if Manufacturer is unable to secure orders from third parties for all time will constitute a breach of the Anticipated Shortfall within thirty (30) days of receipt of a Shortfall Notice, it shall deliver a Reimbursement Notice to Russell. The Reimbursement Notice shall ixxxxxx a calculation of the Idle Capacity Payment in accordance with the sample formula contained in Paragraph 1(e). If Manufacturer sells the Anticipated Shortfall to a third party, the Idle Capacity Payment will be adjusted for the difference between the outside selling price conversion and the agreed upon conversion by Russell. If Manufacturer's sales of Anticxxxxxx Shortfall exceed the amount which would have constituted the Price if Russell had purchased the Anticipated Shoxxxxxx, such excess will be used by Manufacturer as an offset to future Idle Capacity Payments due from Russellcontract.
(ve) Russell QuickLogic shall remit the Idle Caxxxxxx Payment to Manufacturer within thirty place purchase orders (30"Purchase Orders") days from the date of receipt for such quantities of the Reimbursement Notice.
(vi) If, prior to or during wafers as and when it requires. The Purchase Orders shall be open purchase orders for a month, Manufacturer determines that there will be a Manufacturer's Shortfall, Manufacturer shall provide prompt written notice to Russell. Within ten (10) days fixed quantity of the date Xxxxxxcturer provides notice wafers, and shall normally cover a [*] period commencing one quarter after the placement of the Purchase Order. QuickLogic shall issue release orders for quantities and mix of Products as and when it requires, against this Purchase Order. Such Purchase Orders constitute firm purchase obligations on the part of QuickLogic and shall only be final subject to Russell acceptance by TSMC. TSMC may accept the Purchase Order either by written acknowledgment or by shipment of a Manufacturer's Shortfall, Frxxxxxx will provide the Products ordered. Any such written notice to Russell of either: (A) its agreement to sxxxxx xhe Manufacturer's Shortfall in accordance with acknowledgment or shipment by TSMC may vary the terms and conditions of this Agreement or (B) its inability to supply the Manufacturer's Shortfall in accordance Purchase Orders consistent with the terms and conditions of this Agreement. In Notwithstanding the event of a Manufacturer's Shortfall above, the average cycle time per masking step for QuickLogic Products shall be at least as short as those products supplied to other * An asterisk indicates confidential material that has been omitted from this document and Frontier's notice of inability to supply Manufacturer's Shortfall or its failure to supply Manufacturer's Shortfall in accordance filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. TSMC customers using similar device geometry in similar volumes from the same TSMC fab.
(f) If QuickLogic notifies TSMC in writing that modifications to the Quality and Reliability Specifications in Exhibit F are required, including modifications to mask tooling or testing, TSMC shall use commercially reasonable efforts to make such modifications within a reasonable period of time after such QuickLogic notification, provided that any adjustments in price, production, shipment schedule, and any other terms and conditions of this Agreement, Russell Agreement shall have the right to purchase xx xxxxnt of yarn equal meet with TSMC approval prior to the Manufacturer's Shortfall from making of such modifications. It is understood that all costs incurred as a third party. In this event, Russell's obligation to purchase the Annual Xxxxxxm result of making such modifications (including retooling cost) shall be reduced borne by QuickLogic.
(g) QuickLogic may, from time to time, change the mix of Products, or add or substitute similar types of Products, made using the Process, and TSMC shall use reasonable efforts to produce such Products as requested. All costs incurred as a result of additional types of Products shall be borne by QuickLogic. The prices for any additional types of Products which had not been previously quoted shall be negotiated by the amount of the Manufacturer's Shortfall and Manufacturer shall pay to Russell the Manufacturer's Shortfall Payment xxxhin thirty (30) days of receipt of written notice from Russellparties.
Appears in 1 contract
Samples: Agreement (Quicklogic Corporation)
Supply. (a) Obligations 6.1 During the term of Russell this Agreement, DOBFAR shall manufacture, label and Manufacturer
(i) Russell agrees xx xxxxhase Yarn from Manufacturer in mutually agreed upon counts package, ship and deliver the Product for Russell's use in manufacturing apparel prxxxxxx. Xubject to SAGENT on the terms and conditions of this Agreement, during each Year of the Term of this Agreement, Manufacturer agrees to supply to Russell the Annual Minimum and Russell agxxxx xx purchase from Manufactuxxx xx least the Annual Minimum.
(ii) Russell shall have the right to purchase Additional Capacity within the terms outlined in Forecasts and Orders (as specified in Paragraph 2(e) herein)this Agreement and in compliance with all requirements of applicable laws, rules and regulations, and all other requirements of any applicable cGMP and Specifications. The price for Additional Capacity will be determined in accordance with Schedule C. The terms and conditions for the purchase of the Additional Capacity Product shall be manufactured by DOBFAR at the applicable Manufacturing Facility in accordance with the terms of this Agreement and the Quality Agreement. Except as set forth in Section 7.1, SAGENT shall not be required to order any fixed minimum quantity of Product or any quantity of Product for which it does not actually have a need, notwithstanding any forecast or prior course of dealing.
(iii) If 6.2 During the term of this Agreement, DOBFAR shall be solely responsible for arranging for an FDA-approved third party to manufacture and supply the API necessary to manufacture the Product in accordance with all requirements of applicable laws, rules and regulations, and all other requirements of any applicable cGMP and Specifications and in sufficient quantities to meet SAGENT’s forecasted needs for the Product; provided that DOBFAR shall give written notice to SAGENT in advance of retaining any such third party API supplier. With respect to any third party API supplier that DOBFAR desires to use, DOBFAR shall ensure that such third party API supplier makes its facilities and records relating to the manufacture of the API available for inspection by SAGENT as SAGENT requests from time to time. In the event that during any month Russell fails to timely notify Manufacturxx xx xts intent to utilize all such inspection, SAGENT identifies any instances of noncompliance with the requirements of applicable laws, rules and regulations, applicable cGMP or the Specifications, then DOBFAR shall promptly provide a portion of the Additional Capacitywritten plan for correcting such deficiencies (including a proposed timetable for implementing such corrections) and shall ensure that such deficiencies are corrected, at DOBFAR’s or if Russell notifies Manufacturer that it intxxxx xx use a portion of the Additional Capacitysuch third party API supplier’s sole expense, Manufacturer shall be free to sell any unused portion of the Additional Capacity to a third party. Manufacturer may sell any capacity of Yarn in excess of the Annual Minimum and the Additional Capacity to a third party.
(iv) If Russell determines that it will not purchase the monthly pro rata share of the Annual Minimum during a month, Russell shall deliver a Shortfall Notice to Xxxxfacturer as soon as reasonably practicable practicable. If not corrected to enable Manufacturer SAGENT’s satisfaction (or if the third party API supplier does not make its facility and records available for inspection by SAGENT), then DOBFAR shall be required to sell such Anticipated Shortfall secure a different third party API supplier, and to immediately cease using the noncompliant supplier. Subject to Section 6.3, DOBFAR shall be solely responsible for ensuring that the API so supplied to it is of sufficient quality and meets other relevant standards in order for it to be utilized by DOBFAR in the manufacture of the Product in accordance with Section 6.1. [***] Indicates that text has been omitted which is the subject of a confidential treatment request. This text has been separately filed with the Securities and Exchange Commission
6.3 All Product manufactured, shipped and delivered by DOBFAR to SAGENT or SAGENT’s designees under this Agreement shall be packaged and labeled in accordance with this Agreement and the then-current packaging and labeling guidelines provided by SAGENT and in compliance with all requirements of applicable laws, rules and regulations, all other requirements of any applicable cGMP as well as the applicable Specifications and the Registration. SAGENT shall supply DOBFAR with SAGENT’s NDC number(s) for the Product and any trade dress that SAGENT wishes to have included in the labeling for the Product. DOBFAR shall print, either directly or through a third party or parties. Upon receipt party, labels and other printed material to be included as part of the Shortfall NoticeProduct, Manufacturer and the cost of doing so shall be reflected in the price charged by DOBFAR for the Product pursuant to Article 9. From time to time, SAGENT may provide DOBFAR with modified trade dress or logos and upon receipt thereof, DOBFAR shall use its best commercially reasonable efforts to secure orders from third parties incorporate such changes on the Products in accordance with SAGENT’s request. DOBFAR shall provide SAGENT with any modifications to utilize the labeling for the Products as promptly as possible in order to ensure compliance with any and all applicable regulations. SAGENT shall reimburse DOBFAR for all reasonable costs incurred by DOBFAR in making modifications to labeling, branding, or imprinting packaging and/or manufacturing processes to accommodate SAGENT’s new labeling or to accommodate any other changes requested by SAGENT. Such reimbursement shall be made pursuant to invoices submitted by DOBFAR to SAGENT, undisputed amounts on such Anticipated Shortfallinvoices shall be payable within thirty (30) days after SAGENT’s receipt thereof. SAGENT shall cooperate with DOBFAR to ensure that the labeling of the Product complies with the Registration for the Product.
6.4 DOBFAR shall schedule its manufacturing operations so that all Products delivered have the maximum shelf life possible and in any event no Product delivered hereunder shall have less than [***] of shelf life, based on the dating included on such Product’s packaging, remaining at the time of delivery; provided, however, that if Manufacturer is unable SAGENT accepts delivery of Product prior to secure orders from third parties for all the Launch Date and such Product has less than [***] of shelf life, based on the dating included on such Product’s packaging, as of the Anticipated Shortfall within thirty (30) days Launch Date, then DOBFAR will, at no expense to SAGENT, replace such Product as soon as practicable with Product that has at least 75% of receipt of a Shortfall Noticeshelf life, it shall deliver a Reimbursement Notice to Russell. The Reimbursement Notice shall ixxxxxx a calculation based on the dating included on such Product’s packaging, as of the Idle Capacity Payment in accordance with later of (i) the sample formula contained in Paragraph 1(e). If Manufacturer sells the Anticipated Shortfall to a third party, the Idle Capacity Payment will be adjusted for the difference between the outside selling price conversion and the agreed upon conversion by Russell. If Manufacturer's sales of Anticxxxxxx Shortfall exceed the amount which would have constituted the Price if Russell had purchased the Anticipated Shoxxxxxx, such excess will be used by Manufacturer as an offset to future Idle Capacity Payments due from Russell.
Launch Date or (vii) Russell shall remit the Idle Caxxxxxx Payment to Manufacturer within thirty (30) days from the date of receipt of the Reimbursement Noticesuch replacement Product is actually delivered to SAGENT.
(vi) If, prior to or during a month, Manufacturer determines that there will be a Manufacturer's Shortfall, Manufacturer shall provide prompt written notice to Russell. Within ten (10) days of the date Xxxxxxcturer provides notice to Russell of a Manufacturer's Shortfall, Frxxxxxx will provide written notice to Russell of either: (A) its agreement to sxxxxx xhe Manufacturer's Shortfall in accordance with the terms and conditions of this Agreement or (B) its inability to supply the Manufacturer's Shortfall in accordance with the terms and conditions of this Agreement. In the event of a Manufacturer's Shortfall and Frontier's notice of inability to supply Manufacturer's Shortfall or its failure to supply Manufacturer's Shortfall in accordance with the terms of this Agreement, Russell shall have the right to purchase xx xxxxnt of yarn equal to the Manufacturer's Shortfall from a third party. In this event, Russell's obligation to purchase the Annual Xxxxxxm shall be reduced by the amount of the Manufacturer's Shortfall and Manufacturer shall pay to Russell the Manufacturer's Shortfall Payment xxxhin thirty (30) days of receipt of written notice from Russell.
Appears in 1 contract
Samples: Manufacture and Supply Agreement (Sagent Holding Co.)
Supply. (a) Obligations of Russell and Manufacturer
(i) Russell agrees xx xxxxhase Yarn Hospira shall Manufacture Product for Genzyme from Manufacturer Bulk that Genzyme shall supply to Hospira in mutually agreed upon counts quantities sufficient to satisfy Hospira’s gross manufacturing requirements of Product. Unless otherwise specified in the relevant Project SOW, Genzyme shall deliver all required quantities of Bulk for Russell's use in manufacturing apparel prxxxxxx. Xubject a particular Product no later than thirty (30) days prior to the terms date that Manufacturing of such Product is scheduled to commence. Hospira’s use of Bulk received from Genzyme shall be limited to those purposes contemplated by this Master Agreement and conditions the Manufacture of Product for Genzyme. Genzyme shall deliver Bulk [**] Hospira’s Facility for all deliveries, pursuant to no-cost Purchase Orders that Hospira issues to Genzyme. Genzyme shall be responsible for all costs of transport and carriage insurance. In the event Genzyme fails more than once to deliver the required quantities of Bulk for a particular Product at least [**] days prior to the date that Manufacturing of such Product is scheduled to commence, or as specified in the relevant Project SOW, the Alliance Team leaders shall meet to establish a remediation plan to address the failure. If Genzyme fails more than twice to deliver the required quantities of Bulk for a particular Product at least [**] days prior to the date that [**] = Portions of this Agreementexhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Manufacturing of such Product is scheduled to commence, during each Year or as specified in the relevant Project SOW, then a member of the Term senior management team from each Party shall meet with one another to review the remediation plan established by the Alliance Team and determine whether Genzyme is capable of this Agreementdelivering Bulk within the specified delivery timeframe. The Parties will at that time determine whether Hospira will continue with the Manufacture the Product in question or, Manufacturer agrees to supply to Russell alternatively, decide in the Annual Minimum and Russell agxxxx xx purchase from Manufactuxxx xx least best interests of the Annual MinimumParties that Hospira no longer manufacture such Product.
(ii) Russell With each delivery of Bulk, Genzyme will include a certificate of analysis, signed by an authorized individual from Genzyme’s Quality Group (or his/her designee) containing basic information regarding the Bulk, including: (A) the manufacturing date of the batch/lot delivered; (B) the batch/lot number; (C) the quantity of Bulk in such batch/lot as shipped to Hospira; (D) an indication of the expiry date of the batch/lot of Bulk by which Hospira must begin filling operations; and (E) the testing (if any) to which the batch/lot of Bulk has been subjected and the test results.
(iii) Unless otherwise specified in the relevant Project SOW, within [**] calendar days of Hospira’s receipt of any Bulk supplied by Genzyme hereunder, Hospira shall: (A) perform an identification test on the Bulk and confirm the shipment quantity; and (B) notify Genzyme of any inaccuracies with respect to quantity or of any claim that any portion of the shipment fails the identification test. In the event Hospira notifies Genzyme of any deficiency in the quantity of Bulk received, Genzyme shall promptly investigate such deficiency and provide Hospira with instructions on how to handle the Bulk. Genzyme may ship to Hospira, at Genzyme’s expense, the quantity of Bulk necessary to complete the Bulk shipment. In the event Hospira notifies Genzyme that the Bulk shipment does not conform to the Bulk Specifications, as evidenced by the results of the relevant identification test, Genzyme shall have the right to purchase Additional Capacity within the terms outlined in Forecasts and Orders (as specified in Paragraph 2(e) herein). The price for Additional Capacity will be determined in accordance with Schedule C. The terms and conditions for the purchase of the Additional Capacity shall be in accordance with the terms of this Agreement.
(iii) If during any month Russell fails to timely notify Manufacturxx xx xts intent to utilize all or a portion of the Additional Capacity, or if Russell notifies Manufacturer that it intxxxx xx use a portion of the Additional Capacity, Manufacturer shall be free to sell any unused portion of the Additional Capacity to a third party. Manufacturer may sell any capacity of Yarn in excess of the Annual Minimum and the Additional Capacity to a third partyconfirm such findings at Hospira’s Facility.
(iv) If Russell Genzyme determines that it will such shipment of Bulk did, in fact, conform to the Bulk Specifications, the Parties shall submit samples of such shipment to a mutually acceptable independent expert for testing. If such independent expert determines that the shipment conformed to the Bulk Specifications, Hospira shall bear all expenses of shipping and testing such shipment samples. If Genzyme or such independent expert confirms that such shipment did not purchase meet the monthly pro rata share Bulk Specifications, Genzyme shall use commercially reasonable efforts to replace, at no cost to Hospira, the portion of the Annual Minimum during a month, Russell shall deliver a Shortfall Notice Bulk shipment which does not conform to Xxxxfacturer as soon as reasonably practicable to enable Manufacturer to sell such Anticipated Shortfall to a third party or partiesthe Bulk Specifications and bear all expenses of shipping and testing the shipment samples. Upon receipt of Notwithstanding the Shortfall Notice, Manufacturer shall use its best efforts to secure orders from third parties to utilize such Anticipated Shortfall; provided, however, that if Manufacturer is unable to secure orders from third parties for all of the Anticipated Shortfall within thirty (30) days of receipt of a Shortfall Notice, it shall deliver a Reimbursement Notice to Russell. The Reimbursement Notice shall ixxxxxx a calculation of the Idle Capacity Payment in accordance with the sample formula contained in Paragraph 1(e). If Manufacturer sells the Anticipated Shortfall to a third partyforegoing, the Idle Capacity Payment will be adjusted for the difference between the outside selling price conversion and the agreed upon conversion independent expert may also determine that additional sample testing by Russell. If Manufacturer's sales of Anticxxxxxx Shortfall exceed the amount which would have constituted the Price if Russell had purchased the Anticipated Shoxxxxxx, such excess will be used by Manufacturer as an offset to future Idle Capacity Payments due from Russellindependent laboratory is necessary.
(v) Russell shall remit the Idle Caxxxxxx Payment to Manufacturer within thirty (30) days from the date of receipt of the Reimbursement Notice.
(vi) If, prior to or during a month, Manufacturer determines that there will be a Manufacturer's Shortfall, Manufacturer shall provide prompt written notice to Russell. Within ten (10) days of the date Xxxxxxcturer provides notice to Russell of a Manufacturer's Shortfall, Frxxxxxx will provide written notice to Russell of either: (A) its agreement to sxxxxx xhe Manufacturer's Shortfall in accordance with the terms and conditions of this Agreement or (B) its inability to supply the Manufacturer's Shortfall in accordance with the terms and conditions of this Agreement. In the event of a Manufacturer's Shortfall and Frontier's notice of inability to supply Manufacturer's Shortfall or its failure to supply Manufacturer's Shortfall in accordance with the terms of this Agreement, Russell shall have the right to purchase xx xxxxnt of yarn equal to the Manufacturer's Shortfall from a third party. In this event, Russell's obligation to purchase the Annual Xxxxxxm shall be reduced by the amount of the Manufacturer's Shortfall and Manufacturer shall pay to Russell the Manufacturer's Shortfall Payment xxxhin thirty (30) days of receipt of written notice from Russell.
Appears in 1 contract
Supply. (a) Obligations Hospira shall manufacture the Products for Genzyme from Bulk that Genzyme shall supply to Hospira at no cost. Genzyme shall supply Bulk to Hospira in quantities sufficient to satisfy Hospira’s gross manufacturing requirements of Russell the Products. Hospira’s use of Bulk received from Genzyme shall be limited to development contemplated by this Agreement and Manufacturer
the manufacture of the Products for Genzyme. Genzyme shall ship all required quantities of Bulk: (i) Russell agrees xx xxxxhase Yarn from Manufacturer [**] for deliveries originating in mutually agreed upon counts for Russell's use in manufacturing apparel prxxxxxx. Xubject to the terms and conditions of this Agreement, during each Year of the Term of this Agreement, Manufacturer agrees to supply to Russell the Annual Minimum and Russell agxxxx xx purchase from Manufactuxxx xx least the Annual Minimum.
United States; or (ii) Russell [**] for deliveries originating outside the United States, to Hospira’s manufacturing plant in [**] (the “Facility”), pursuant to no-cost purchase orders that Hospira issues to Genzyme. Genzyme shall have be responsible for all costs of transport and carriage insurance. Within [**] days of Hospira’s receipt of any Bulk, excluding [**] Bulk in which case within [**] days, supplied by Genzyme hereunder, Hospira shall: (i) perform an identification test on the right Bulk and confirm the shipment quantity; and (ii) notify Genzyme of any inaccuracies with respect to purchase Additional Capacity within the terms outlined in Forecasts and Orders (as specified in Paragraph 2(e) herein). The price for Additional Capacity will be determined in accordance with Schedule C. The terms and conditions for the purchase quantity, or of any claim that any portion of the Additional Capacity shipment fails the identification test. Hospira shall be manufacture the Products from the Bulk in accordance with the terms of this Agreement.
(iii) If during any month Russell fails to timely notify Manufacturxx xx xts intent to utilize all or a portion of the Additional CapacityProduct Specifications, or if Russell notifies Manufacturer that it intxxxx xx use a portion of the Additional Capacity, Manufacturer shall be free to sell any unused portion of the Additional Capacity to a third party. Manufacturer may sell any capacity of Yarn in excess of the Annual Minimum and the Additional Capacity to a third party.
(iv) If Russell determines that it will not purchase the monthly pro rata share of the Annual Minimum during a month, Russell shall deliver a Shortfall Notice to Xxxxfacturer as soon as reasonably practicable to enable Manufacturer to sell such Anticipated Shortfall to a third party or parties. Upon generally within [**] days after receipt of the Shortfall Notice, Manufacturer shall use its best efforts to secure orders from third parties to utilize such Anticipated Shortfallthereof; provided, however, that if Manufacturer is unable to secure orders from third parties for all of Hospira will manufacture the Anticipated Shortfall [**] Product(s) within thirty (30) [**] days of after receipt of a Shortfall Notice, it shall deliver a Reimbursement Notice to Russell. The Reimbursement Notice shall ixxxxxx a calculation of the Idle Capacity Payment in accordance with the sample formula contained in Paragraph 1(e). If Manufacturer sells the Anticipated Shortfall to a third party, the Idle Capacity Payment will be adjusted for the difference between the outside selling price conversion and the agreed upon conversion by Russell. If Manufacturer's sales of Anticxxxxxx Shortfall exceed the amount which would have constituted the Price if Russell had purchased the Anticipated Shoxxxxxx, such excess will be used by Manufacturer as an offset to future Idle Capacity Payments due from Russell.
(v) Russell shall remit the Idle Caxxxxxx Payment to Manufacturer within thirty (30) days from the date of receipt of the Reimbursement Notice.
(vi) If, [**] Bulk or prior to or during a month, Manufacturer determines that there will be a Manufacturer's Shortfall, Manufacturer shall provide prompt written notice to Russell. Within ten (10) days of the Genzyme’s stated expiry date Xxxxxxcturer provides notice to Russell of a Manufacturer's Shortfall, Frxxxxxx will provide written notice to Russell of either: (A) its agreement to sxxxxx xhe Manufacturer's Shortfall in accordance with the terms and conditions of this Agreement or (B) its inability to supply the Manufacturer's Shortfall in accordance with the terms and conditions of this Agreementfor such Bulk. In the event Hospira notifies Genzyme of a Manufacturer's Shortfall and Frontier's notice any deficiency in the quantity of inability Bulk received, Genzyme shall promptly ship to supply Manufacturer's Shortfall or its failure Hospira, [**], the quantity of Bulk necessary to supply Manufacturer's Shortfall in accordance with complete the terms of this AgreementBulk shipment. In the event Hospira notifies Genzyme that the Bulk shipment does not conform to the Bulk Specifications, Russell Genzyme shall have the right to purchase xx xxxxnt confirm such findings at Hospira’s manufacturing location. If Genzyme determines that such shipment of yarn equal Bulk conformed to the Manufacturer's Shortfall from Bulk Specifications, the Parties shall submit samples of such shipment to a third partymutually acceptable independent laboratory for testing. In this eventIf such independent laboratory determines that the shipment conformed to the Bulk Specifications, Russell's obligation Hospira shall bear all expenses of shipping and testing such shipment samples. If Genzyme or such independent laboratory confirms that such shipment did not meet the Bulk Specifications, Genzyme shall replace, at no cost to purchase Hospira, the Annual Xxxxxxm shall be reduced by the amount portion of the Manufacturer's Shortfall Bulk shipment which does not conform to the Bulk Specifications and Manufacturer shall pay to Russell bear all expenses of shipping and testing the Manufacturer's Shortfall Payment xxxhin thirty (30) days of receipt of written notice from Russellshipment samples.
Appears in 1 contract
Samples: Technology Transfer and Supply Agreement (Genzyme Corp)
Supply. (a) Obligations of Russell and Manufacturer
(i) Russell agrees xx xxxxhase Yarn from Manufacturer in mutually agreed upon counts for Russell's use in manufacturing apparel prxxxxxx. Xubject Subject to the terms and conditions of this Agreement, during each Year the Term, Spark shall Manufacture and supply the Products exclusively (except for Spark’s and its Affiliates’, licensees’ and collaborators’ requirements in the Spark Territory) to Novartis and its Affiliates and their respective Sublicensees and distributors, and Novartis agrees to purchase from Spark, all of the Term requirements of Novartis and its Affiliates and their respective Sublicensees and distributors for the Products in the Novartis Territory.
(b) Notwithstanding anything to the contrary set forth herein, and subject to Section 2.1(c), the Parties acknowledge and agree that unless otherwise agreed Novartis shall forecast and order its and its Affiliates’ and their respective Sublicensees’ and distributors’ requirements for Drug Product and Diluent Product in terms of number of vials, and that Novartis shall pay for Drug Product and Diluent Product on a per vial basis, provided that in any given Purchase Order, Novartis shall not order more than [**] vials of Drug Product. The Parties acknowledge that the actual number of vials of Drug Product may vary among Batches of Drug Substance. Except for Supply Failures, any variance between the Drug Products ordered by Novartis and the Resulting Vials of Drug Product delivered to Novartis in compliance with the Product Warranty shall be subject to the yield mechanism in Section 2.5, and it shall not be a breach of this AgreementAgreement if the Resulting Vials of Drug Product is less than the number of vials ordered by Novartis.
(c) At any point during the Term Novartis may, Manufacturer agrees in its discretion, notify Spark in writing that it shall forecast and order Batches of Drug Substance, and that Spark shall deliver to supply Novartis Batches of Drug Substance instead of Drug Product. Novartis shall pay for Batches of Drug Substance on a per batch basis instead of on a per vial basis. Any such notice shall be given at least [**] prior to Russell the Annual Minimum first required delivery date of any Batches of Drug Substance. Following such notice, the Parties will mutually agree on the applicable lead time for delivery, the appropriate delivery Incoterm, and Russell agxxxx xx the process for moving from placing Purchase Orders for Drug Products to placing Purchase Orders for Batches of Drug Substance and how to handle any open Purchase Orders for Drug Products. If it elects to order Batches of Drug Substance instead of Drug Product, Novartis may also, in its discretion, notify Spark in writing that it no longer wishes to purchase Diluent Product directly from Manufactuxxx xx least Spark and/or that it no longer wishes the Annual Minimum.Fill and Finish Subcontractor to fill and finish the Drug Product, and Spark shall:
(i) provide (or procure the provision of) to Novartis or its designated Affiliate or Third Party manufacturer:
(A) all technical documentation (including master Batch Records), specifications, procedures and know-how in its possession or control that are reasonably required for the filling, finishing and release testing of Drug Products or Diluent Products (as the case may be); and
(B) samples of materials relating to the Manufacture of Drug Products or Diluent Products (as the case may be), including process descriptions, master Batch Records and other related materials, in all cases, to the extent controlled by Spark at the date of the notice and to the extent necessary or reasonably useful for the Manufacture of Drug Products or Diluent Products (as the case may be); and
(ii) Russell shall have the right make reasonably available to purchase Additional Capacity within the terms outlined in Forecasts Novartis, relevant scientific and Orders technical personnel to answer questions, provide on-site support at one fill and finish facility, and to train personnel from such facilities, and/or provide instruction relating to Manufacture of Drug Products or Diluent Products (as specified in Paragraph 2(ethe case may be) herein). The price during one site visit to each facility for Additional Capacity will be determined in accordance a period of no more than [**] each; and
(iii) cooperate with Schedule C. The terms and conditions Novartis to transition any relevant analytical test methods for the Drug Product and/or Diluent Product to Novartis or its Third Party manufacturer, which cooperation shall be limited to one visit per analytical testing site for a period of no more than [**] each; and
(iv) [**].
(d) Notwithstanding anything to the contrary set forth in this Agreement or in the License Agreement, Novartis and its Sublicensees and their respective distributors shall purchase Products only for purposes permitted under the License Agreement. In addition, all Diluent Product purchased by Novartis shall be used only for purposes of administration of the Additional Capacity shall be Drug Substance to end users in accordance with the terms of this Agreementrelevant Regulatory Approval.
(iiie) If during any month Russell fails to timely notify Manufacturxx xx xts intent to utilize all By [**] (or a portion such other date as the Parties may agree in writing), Novartis will determine in its sole discretion whether the vials of the Additional Capacity, or if Russell notifies Manufacturer that it intxxxx xx use a portion of the Additional Capacity, Manufacturer Diluent Product and Drug Product shall be free to sell any unused portion of the Additional Capacity to delivered labeled with a third party. Manufacturer may sell any capacity of Yarn in excess of the Annual Minimum and the Additional Capacity to a third party.
(iv) If Russell determines that it will not purchase the monthly pro rata share of the Annual Minimum during a month, Russell shall deliver a Shortfall Notice to Xxxxfacturer single universal label as soon specified by Novartis or as reasonably practicable to enable Manufacturer to sell such Anticipated Shortfall to a third party or parties. Upon receipt of the Shortfall Notice, Manufacturer shall use its best efforts to secure orders from third parties to utilize such Anticipated Shortfall; provided, however, that if Manufacturer is unable to secure orders from third parties for all of the Anticipated Shortfall within thirty (30) days of receipt of a Shortfall Notice, it shall deliver a Reimbursement Notice to Russell. The Reimbursement Notice shall ixxxxxx a calculation of the Idle Capacity Payment in accordance with the sample formula contained in Paragraph 1(e). If Manufacturer sells the Anticipated Shortfall to a third party, the Idle Capacity Payment will be adjusted naked vials for the difference between the outside selling price conversion Novartis Territory and the agreed upon conversion by Russell. If Manufacturer's sales of Anticxxxxxx Shortfall exceed the amount which would have constituted the Price if Russell had purchased the Anticipated Shoxxxxxx, such excess will be used by Manufacturer as an offset to future Idle Capacity Payments due from Russell.
(v) Russell shall remit the Idle Caxxxxxx Payment to Manufacturer within thirty (30) days from the date of receipt of the Reimbursement Notice.
(vi) If, prior to or during a month, Manufacturer determines that there will be a Manufacturer's Shortfall, Manufacturer shall provide prompt written notice to Russell. Within ten (10) days of the date Xxxxxxcturer provides notice to Russell of a Manufacturer's Shortfall, Frxxxxxx will provide written notice of its decision to Russell of either: (A) its agreement to sxxxxx xhe Manufacturer's Shortfall in accordance with the terms and conditions of this Agreement or (B) its inability Spark. Spark shall not be obligated to supply the Manufacturer's Shortfall in accordance any Diluent Product or Drug Product with the terms and conditions of this Agreement. In the event of a Manufacturer's Shortfall and Frontier's notice of inability single universal label until Novartis has supplied to supply Manufacturer's Shortfall or its failure to supply Manufacturer's Shortfall in accordance with the terms of this Agreement, Russell shall have the right to purchase xx xxxxnt of yarn equal to the Manufacturer's Shortfall from Spark a third party. In this event, Russell's obligation to purchase the Annual Xxxxxxm shall be reduced by the amount PDF file of the Manufacturer's Shortfall and Manufacturer shall pay to Russell applicable single universal label by such date as the Manufacturer's Shortfall Payment xxxhin thirty (30) days of receipt Parties may mutually agree in writing following Novartis’ provision of written notice from Russellof its decision to Spark.
Appears in 1 contract
Supply. (a) Obligations of Russell and Manufacturer
(i) Russell agrees xx xxxxhase Yarn from Manufacturer in mutually agreed upon counts for Russell's use in manufacturing apparel prxxxxxx. Xubject to the terms and conditions of this Agreement, during each Year of the Term of this Agreement, Manufacturer agrees to supply to Russell the Annual Minimum and Russell agxxxx xx purchase from Manufactuxxx xx least the Annual Minimum.
(ii) Russell A. The Relevant Project Components shall have the right to purchase Additional Capacity within the terms outlined in Forecasts and Orders (as specified in Paragraph 2(e) herein). The price for Additional Capacity will be determined manufactured in accordance with Schedule C. The terms the specifications attached hereto as Appendix A (the “Specifications”) and conditions for the purchase of the Additional Capacity shall be in accordance with the terms of this the Quality Agreement between the parties, effective as of September 22, 2015, as may be amended from time to time by the mutual written agreement of the parties (the “Quality Agreement”). CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED WITH [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(iii) B. During the Term, Greatbatch will manufacture the Relevant Project Components at its Plymouth, Minnesota facility and then likely transfer the manufacturing to another Greatbatch facility. If during any month Russell fails Greatbatch desires to timely notify Manufacturxx xx xts intent to utilize all or a portion relocate the manufacturing of the Additional CapacityRelevant Project Components to another Greatbatch facility, or if Russell notifies Manufacturer that it intxxxx xx use a portion of the Additional Capacity, Manufacturer Greatbatch shall be free to sell any unused portion of the Additional Capacity to a third party. Manufacturer may sell any capacity of Yarn in excess of the Annual Minimum and the Additional Capacity to a third party.
(iv) If Russell determines that it will not purchase the monthly pro rata share of the Annual Minimum during a month, Russell shall deliver a Shortfall Notice to Xxxxfacturer as soon as reasonably practicable to enable Manufacturer to sell such Anticipated Shortfall to a third party or parties. Upon receipt of the Shortfall Notice, Manufacturer shall use its best efforts to secure orders from third parties to utilize such Anticipated Shortfall; provided, however, that if Manufacturer is unable to secure orders from third parties for all of the Anticipated Shortfall within thirty (30) days of receipt of a Shortfall Notice, it shall deliver a Reimbursement Notice to Russell. The Reimbursement Notice shall ixxxxxx a calculation of the Idle Capacity Payment in accordance with the sample formula contained in Paragraph 1(e). If Manufacturer sells the Anticipated Shortfall to a third party, the Idle Capacity Payment will be adjusted for the difference between the outside selling price conversion and the agreed upon conversion by Russell. If Manufacturer's sales of Anticxxxxxx Shortfall exceed the amount which would have constituted the Price if Russell had purchased the Anticipated Shoxxxxxx, such excess will be used by Manufacturer as an offset to future Idle Capacity Payments due from Russell.
(v) Russell shall remit the Idle Caxxxxxx Payment to Manufacturer within thirty (30) days from the date of receipt of the Reimbursement Notice.
(vi) If, prior to or during a month, Manufacturer determines that there will be a Manufacturer's Shortfall, Manufacturer shall provide prompt written notice to Russell. Within ten (10) days of the date Xxxxxxcturer provides notice to Russell of a Manufacturer's Shortfall, Frxxxxxx will provide written notice to Russell QiG Group at least [***] months prior to Greatbatch’s proposed date of either: such relocation, and shall provide such other information reasonably required by QiG Group with respect to such proposed new location. Following the notice, Greatbatch shall deliver to QiG Group a final qualification report and final qualification parts in connection with the relocation indicating Relevant Project Component equivalence at the new location (A) its agreement “Validation Documentation”). Greatbatch shall not ship any Relevant Project Component manufactured at the new facility until Greatbatch’s receipt of a written notice from QiG Group that it is ready to sxxxxx xhe Manufacturer's Shortfall receive Relevant Project Components manufactured at the new facility (the “Facility Approval Notice”). QiG Group will use best efforts to achieve all necessary regulatory approvals as soon as possible after QiG Group’s approval of the Validation Documentation. If QiG Group does not issue the Facility Approval Notice within [***] days after all regulatory approvals necessary to manufacture the Relevant Project Component at the new location have been obtained and Greatbatch has reasonably demonstrated that it can manufacture the Relevant Project Components in accordance with the terms and conditions of this Agreement or at such new location, then all prices for the Relevant Project Components will automatically increase by [***] percent (B[***]%) its inability unless and until QiG Group issues the Facility Approval Notice. QiG Group shall provide reasonable cooperation to supply the Manufacturer's Shortfall Greatbatch in accordance connection with the terms and conditions qualification of such new facility. Notwithstanding anything in this Agreement. In the event of a Manufacturer's Shortfall and Frontier's notice of inability to supply Manufacturer's Shortfall or its failure to supply Manufacturer's Shortfall in accordance with the terms of this Agreement, Russell shall have the right to purchase xx xxxxnt of yarn equal Agreement to the Manufacturer's Shortfall from a third party. In this eventcontrary, Russell's obligation to purchase QiG Group understands and agrees that the Annual Xxxxxxm shall be reduced by the amount relocation of the Manufacturer's Shortfall manufacturing facility from the Plymouth, Minnesota facility is accounted for in the pricing in Appendix B, and Manufacturer shall pay to Russell the Manufacturer's Shortfall Payment xxxhin thirty (30) days therefore, no pricing adjustments will be made as result of receipt of written notice from Russellsuch relocation.
Appears in 1 contract
Samples: Supply Agreement (Nuvectra Corp)
Supply. (a) Obligations of Russell and Manufacturer
(i) Russell agrees xx xxxxhase Yarn from Manufacturer in mutually agreed upon counts for Russell's use in manufacturing apparel prxxxxxx. Xubject to the terms and conditions of this Agreement, during each Year of the Term of this Agreement, Manufacturer agrees to supply to Russell the Annual Minimum and Russell agxxxx xx purchase from Manufactuxxx xx least the Annual Minimum.
(ii) Russell A. The Relevant Project Components shall have the right to purchase Additional Capacity within the terms outlined in Forecasts and Orders (as specified in Paragraph 2(e) herein). The price for Additional Capacity will be determined manufactured in accordance with Schedule C. The terms the specifications attached hereto as Appendix A (the “Specifications”) and conditions for the purchase of the Additional Capacity shall be in accordance with the terms of this the Quality Agreement between the parties, effective as of September 22, 2015, as may be amended from time to time by the mutual written agreement of the parties (the “Quality Agreement”).
(iii) B. During the Term, Greatbatch will manufacture the Relevant Project Components at its Plymouth, Minnesota facility and then likely transfer the manufacturing to another Greatbatch facility. If during any month Russell fails Greatbatch desires to timely notify Manufacturxx xx xts intent to utilize all or a portion relocate the manufacturing of the Additional CapacityRelevant Project Components to another Greatbatch facility, or if Russell notifies Manufacturer that it intxxxx xx use a portion of the Additional Capacity, Manufacturer Greatbatch shall be free to sell any unused portion of the Additional Capacity to a third party. Manufacturer may sell any capacity of Yarn in excess of the Annual Minimum and the Additional Capacity to a third party.
(iv) If Russell determines that it will not purchase the monthly pro rata share of the Annual Minimum during a month, Russell shall deliver a Shortfall Notice to Xxxxfacturer as soon as reasonably practicable to enable Manufacturer to sell such Anticipated Shortfall to a third party or parties. Upon receipt of the Shortfall Notice, Manufacturer shall use its best efforts to secure orders from third parties to utilize such Anticipated Shortfall; provided, however, that if Manufacturer is unable to secure orders from third parties for all of the Anticipated Shortfall within thirty (30) days of receipt of a Shortfall Notice, it shall deliver a Reimbursement Notice to Russell. The Reimbursement Notice shall ixxxxxx a calculation of the Idle Capacity Payment in accordance with the sample formula contained in Paragraph 1(e). If Manufacturer sells the Anticipated Shortfall to a third party, the Idle Capacity Payment will be adjusted for the difference between the outside selling price conversion and the agreed upon conversion by Russell. If Manufacturer's sales of Anticxxxxxx Shortfall exceed the amount which would have constituted the Price if Russell had purchased the Anticipated Shoxxxxxx, such excess will be used by Manufacturer as an offset to future Idle Capacity Payments due from Russell.
(v) Russell shall remit the Idle Caxxxxxx Payment to Manufacturer within thirty (30) days from the date of receipt of the Reimbursement Notice.
(vi) If, prior to or during a month, Manufacturer determines that there will be a Manufacturer's Shortfall, Manufacturer shall provide prompt written notice to Russell. Within ten (10) days of the date Xxxxxxcturer provides notice to Russell of a Manufacturer's Shortfall, Frxxxxxx will provide written notice to Russell QiG Group at least [***] months prior to Greatbatch’s proposed date of either: such relocation, and shall provide such other information reasonably required by QiG Group with respect to such proposed new location. Following the notice, Greatbatch shall deliver to QiG Group a final qualification report and final qualification parts in connection with the relocation indicating CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED WITH [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Relevant Project Component equivalence at the new location (A) its agreement “Validation Documentation”). Greatbatch shall not ship any Relevant Project Component manufactured at the new facility until Greatbatch’s receipt of a written notice from QiG Group that it is ready to sxxxxx xhe Manufacturer's Shortfall receive Relevant Project Components manufactured at the new facility (the “Facility Approval Notice”). QiG Group will use best efforts to achieve all necessary regulatory approvals as soon as possible after QiG Group’s approval of the Validation Documentation. If QiG Group does not issue the Facility Approval Notice within [***] days after all regulatory approvals necessary to manufacture the Relevant Project Component at the new location have been obtained and Greatbatch has reasonably demonstrated that it can manufacture the Relevant Project Components in accordance with the terms and conditions of this Agreement or at such new location, then all prices for the Relevant Project Components will automatically increase by [***] percent (B[***]%) its inability unless and until QiG Group issues the Facility Approval Notice. QiG Group shall provide reasonable cooperation to supply the Manufacturer's Shortfall Greatbatch in accordance connection with the terms and conditions qualification of such new facility. Notwithstanding anything in this Agreement. In the event of a Manufacturer's Shortfall and Frontier's notice of inability to supply Manufacturer's Shortfall or its failure to supply Manufacturer's Shortfall in accordance with the terms of this Agreement, Russell shall have the right to purchase xx xxxxnt of yarn equal Agreement to the Manufacturer's Shortfall from a third party. In this eventcontrary, Russell's obligation to purchase QiG Group understands and agrees that the Annual Xxxxxxm shall be reduced by the amount relocation of the Manufacturer's Shortfall manufacturing facility from the Plymouth, Minnesota facility is accounted for in the pricing in Appendix B, and Manufacturer shall pay to Russell the Manufacturer's Shortfall Payment xxxhin thirty (30) days therefore, no pricing adjustments will be made as result of receipt of written notice from Russellsuch relocation.
Appears in 1 contract
Samples: Supply Agreement (Qig Group, LLC)
Supply. (a) Obligations 2.1 Requests for design will be placed as described in Exhibit B, and orders for Oligonucleotide synthesis will be placed by Buyer according to process described in Exhibit B. All terms and conditions of Russell and Manufacturer
(i) Russell agrees xx xxxxhase Yarn from Manufacturer in mutually agreed upon counts for Russell's use in manufacturing apparel prxxxxxx. Xubject to this Agreement shall supersede any terms or conditions of said Purchase Order, which modify or are otherwise inconsistent with the terms and conditions of this Agreement, during each Year of the Term of this Agreement, Manufacturer agrees to supply to Russell the Annual Minimum and Russell agxxxx xx purchase from Manufactuxxx xx least the Annual Minimum.
(ii) Russell shall have the right to purchase Additional Capacity within the terms outlined in Forecasts and Orders (as specified in Paragraph 2(e) herein). The price for Additional Capacity will be determined in accordance with Schedule C. The unless other terms and conditions for the purchase of the Additional Capacity shall are signed by both Parties. All Products will be supplied by SIGMA in accordance with the terms of this AgreementSpecifications in Exhibit A.
2.2 All Product supplied by SIGMA shall be supplied F.O.B. The Woodlands, Texas.
(iii) If during 2.3 SIGMA shall ship Products in a commercially reasonable manner in accordance with Buyer’s reasonable instructions.
2.4 SIGMA shall accept and adhere to the requirements of the Vendor Quality Agreement set out in Exhibit D.
2.5 In the event that any month Russell fails to timely notify Manufacturxx xx xts intent to utilize all or a portion of the Additional Capacityshipment of Products received by Buyer fails to conform to the Specifications, or if Russell notifies Manufacturer that it intxxxx xx use a portion of Buyer may reject the Additional Capacity, Manufacturer shall be free non-conforming Products shipment by giving written notice to sell any unused portion of the Additional Capacity to a third party. Manufacturer may sell any capacity of Yarn in excess of the Annual Minimum and the Additional Capacity to a third party.
(iv) If Russell determines that it will not purchase the monthly pro rata share of the Annual Minimum during a month, Russell shall deliver a Shortfall Notice to Xxxxfacturer as soon as reasonably practicable to enable Manufacturer to sell such Anticipated Shortfall to a third party or parties. Upon receipt of the Shortfall Notice, Manufacturer shall use its best efforts to secure orders from third parties to utilize such Anticipated Shortfall; provided, however, that if Manufacturer is unable to secure orders from third parties for all of the Anticipated Shortfall SIGMA within thirty (30) days of Buyer’s receipt of the Products, which notice shall specify the manner in which the Products fail to meet the Specifications. In the event a Shortfall Notice, it shall deliver a Reimbursement Notice to Russell. The Reimbursement Notice shall ixxxxxx a calculation Product defect could not have been ascertained by Buyer upon reasonable inspection of the Idle Capacity Payment in accordance with Product and analysis thereof, then the sample formula contained in Paragraph 1(e). If Manufacturer sells the Anticipated Shortfall to a third party, the Idle Capacity Payment will be adjusted for the difference between the outside selling price conversion and the agreed upon conversion by Russell. If Manufacturer's sales of Anticxxxxxx Shortfall exceed the amount which would have constituted the Price if Russell had purchased the Anticipated Shoxxxxxx, such excess will be used by Manufacturer as an offset to future Idle Capacity Payments due from Russell.
(v) Russell shall remit the Idle Caxxxxxx Payment to Manufacturer within thirty (30) days day time period referred to herein shall not apply provided that (i) Buyer notifies SIGMA promptly upon having reason to know of such Product defect (but in any event no later than three (3) months from the date of receipt of delivery) and (ii) the Reimbursement Noticelimitation on remedy and liability set out in Section 2.7 shall apply with respect thereto.
(vi) If, prior to or during a month, Manufacturer determines that there will be a Manufacturer's Shortfall, Manufacturer shall provide prompt written notice to Russell. Within ten (10) days of the date Xxxxxxcturer provides notice to Russell of a Manufacturer's Shortfall, Frxxxxxx will provide written notice to Russell of either: (A) its agreement to sxxxxx xhe Manufacturer's Shortfall in accordance with the terms and conditions of this Agreement or (B) its inability to supply the Manufacturer's Shortfall in accordance with the terms and conditions of this Agreement. 2.6 In the event SIGMA does not agree that any such Product failed to meet the Specifications (per Section 2.1) and SIGMA and Buyer cannot reach agreement with respect to such Product, SIGMA will submit the question of a Manufacturer's Shortfall whether the Product failed to meet the Specifications to an independent laboratory selected by SIGMA and Frontier's approved by Buyer for determination. The findings of such laboratory shall be binding upon SIGMA and Buyer and the cost of such determination shall be paid by the party in error.
2.7 Subject to Sections 2.4 and 2.5, SIGMA shall replace any Product not conforming to the Specifications forthwith at its expense within 15 business days of receiving Buyer’s written notice of inability non-conformity. Buyer shall return, at SIGMA’s expense, the nonaccepted Products to supply Manufacturer's Shortfall or SIGMA.
2.8 Except as provided for under Section 4.5 regarding SIGMA’s indemnification obligations for third party claims, the remedies described in Section 2.5 and 2.6 shall be Buyer’s sole remedy and SIGMA’s only liability to Buyer hereunder with respect thereto. CONFIDENTIAL TREATMENT REQUESTED UNDER C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. [****] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION.
2.9 SIGMA warrants that all federal environmental and safety requirements are being and will be followed at its failure to supply Manufacturer's Shortfall in accordance with the terms of this Agreement, Russell facilities. Buyer shall have the right to purchase xx xxxxnt inspect at reasonable times during normal business hours, and on reasonable prior notice, the operations and facilities of yarn equal SIGMA wherein Products are manufactured to evaluate compliance with applicable environmental and occupational health and safety laws and regulations.
2.10 SIGMA shall notify Buyer of significant incidents relating to production of the Product, including but not limited to the Manufacturer's Shortfall following (i) fatalities and/or significant injuries or occupations illnesses; (ii) incidents resulting in property damage of [****] or more; (iii) environmental releases reportable to regulatory agencies; (iv) regulatory agency inspections alleging non-compliance; and (v) request for information, notices of violations or other communication from a third party. In this eventgovernmental agency relating to environmental or occupational health and safety compliance.
2.11 At Buyer’s request, Russell's obligation SIGMA shall provide copies of all relevant environmental licenses and permits pertaining to purchase the Annual Xxxxxxm its operation and shall be reduced notify Buyer of any change in status.
2.12 At Buyer’s request, SIGMA will provide Buyer with copies of all applicable insurance certificates.
2.13 SIGMA agrees that it will conduct all necessary testing of Product as required by the amount of the Manufacturer's Shortfall any and Manufacturer shall pay to Russell the Manufacturer's Shortfall Payment xxxhin thirty (30) days of receipt of written notice from Russellall applicable governmental regulations.
Appears in 1 contract
Supply. 5.1 Teva commits to buy its total demand of the Product for the Territory exclusively from Galena for the term of this Agreement. Galena agrees to exclusively sell and supply Teva with its total demand of the Product in the Territory under agreed conditions pursuant to this Agreement.
5.2 Except as may be otherwise required by a specific Regulatory Authority, Galena will manufacture the Product at the manufacturing facility in [***] (a“the Manufacturing Site”), strictly in accordance with the Specifications and cGMP standards. Galena will enable the applicable Regulatory Authorities to inspect the Manufacturing Site without any delay, provided that any visit shall be coordinated ahead of time with Galena, in order to enable the due registration and commercialization of the Product in the respective markets. Galena will utilize Reasonably Diligent Efforts to ensure that the Manufacturing Site will comply with the requirements and requests of the Regulatory Authorities.
5.3 Galena shall be entitled to use contract manufacturers for the manufacture of the Product, subject to the following conditions:
5.3.1 Galena ensures that Teva is allowed to audit any contract manufacturer before manufacture of the Product by such contract manufacturer is commenced to enable Teva to confirm that the contract manufacturer is reasonably satisfactory to Teva, including without limitation the fact that it is cGMP compliant;
5.3.2 In the event it intends to replace a contract manufacturer, Galena shall procure Teva’s written consent thereto not less than six (6) Obligations months prior to such anticipated replacement;
5.3.3 Teva may refuse to accept the Product manufactured by a contract manufacturer appointed by Galena if Teva’s audit reveals that the contract manufacturer is not satisfactory to it, including without limitation due to the fact such contract manufacturer is not cGMP compliant or as a result of Russell changes to the Product is no longer cGMP compliant.
5.4 Use of a contract manufacturer by Galena shall in no way limit Galena’ obligations under this Agreement and ManufacturerGalena shall be jointly and severally liable for actions and omissions of any contract manufacturers it employs.
(i) Russell agrees xx xxxxhase Yarn from Manufacturer 5.5 Galena will supply the Product in mutually a Finished Form to Teva and its Affiliates.
5.6 Teva shall have the right to inspect the Manufacturing Site used by Galena at reasonable times as agreed upon counts for Russell's between the parties, which access Galena shall use Reasonably Diligent Efforts to procure, which requests will not result in manufacturing apparel prxxxxxxan undue burden to Galena of the manufacturer.
5.7 Galena shall ensure that any Product supplied under this Agreement shall meet its quality Specifications as approved by the Regulatory Authorities in the Territory and contained in the Registration Dossier, including without limitation cGMP standards. Xubject Galena shall ensure that any changes made to such Specifications are not implemented without the prior written approval of the Regulatory Authorities in the Territory and/or Teva’s.
5.8 The supply of the Product by Galena to Teva shall also be subject to the terms and conditions of this Agreement, during each Year of the Term of this Agreement, Manufacturer agrees to supply to Russell the Annual Minimum and Russell agxxxx xx purchase from Manufactuxxx xx least the Annual Minimum.
(ii) Russell shall have the right to purchase Additional Capacity within the terms outlined in Forecasts and Orders (as specified in Paragraph 2(e) herein). The price for Additional Capacity will be determined in accordance with Schedule C. The terms and conditions for the purchase of the Additional Capacity shall be in accordance with the terms of this Agreement.
(iii) If during any month Russell fails to timely notify Manufacturxx xx xts intent to utilize all or a portion of the Additional Capacity, or if Russell notifies Manufacturer that it intxxxx xx use a portion of the Additional Capacity, Manufacturer shall be free to sell any unused portion of the Additional Capacity to a third party. Manufacturer may sell any capacity of Yarn in excess of the Annual Minimum and the Additional Capacity to a third party.
(iv) If Russell determines that it will not purchase the monthly pro rata share of the Annual Minimum during a month, Russell shall deliver a Shortfall Notice to Xxxxfacturer as soon as reasonably practicable to enable Manufacturer to sell such Anticipated Shortfall to a third party or parties. Upon receipt of the Shortfall Notice, Manufacturer shall use its best efforts to secure orders from third parties to utilize such Anticipated Shortfall; provided, however, that if Manufacturer is unable to secure orders from third parties for all of the Anticipated Shortfall within thirty (30) days of receipt of a Shortfall Notice, it shall deliver a Reimbursement Notice to Russell. The Reimbursement Notice shall ixxxxxx a calculation of the Idle Capacity Payment in accordance with the sample formula contained in Paragraph 1(e). If Manufacturer sells the Anticipated Shortfall to a third party, the Idle Capacity Payment will be adjusted for the difference between the outside selling price conversion and the agreed upon conversion by Russell. If Manufacturer's sales of Anticxxxxxx Shortfall exceed the amount which would have constituted the Price if Russell had purchased the Anticipated Shoxxxxxx, such excess will be used by Manufacturer as an offset to future Idle Capacity Payments due from Russell.
(v) Russell shall remit the Idle Caxxxxxx Payment to Manufacturer within thirty (30) days from the date of receipt of the Reimbursement Notice.
(vi) If, prior to or during a month, Manufacturer determines that there will be a Manufacturer's Shortfall, Manufacturer shall provide prompt written notice to Russell. Within ten (10) days of the date Xxxxxxcturer provides notice to Russell of a Manufacturer's Shortfall, Frxxxxxx will provide written notice to Russell of either: (A) its agreement to sxxxxx xhe Manufacturer's Shortfall in accordance with the terms and conditions of this Agreement or (B) its inability to supply the Manufacturer's Shortfall in accordance with the terms and conditions of this Quality Agreement. In the event of any inconsistencies between this Agreement and the Quality Agreement, the provisions of this Agreement shall prevail in all non-quality related matters.
5.9 Galena shall provide Teva with a Manufacturer's Shortfall Certificate of Analysis (signed by a “Qualified Person” designated by Galena) for each batch delivered to Teva in order to confirm that the applicable Product as delivered meets all its Specifications and Frontier's notice cGMP standards. Galena shall provide Teva with any other document already in its possession or which can be reasonably obtained by Galena, and which could be required by the competent Regulatory Authority.
5.10 With the first lot of inability the Product shipped to Teva, Galena shall, at its own expense, send to Teva all necessary samples and standards, including, but not limited to, reference samples, impurities and stability samples, and reference and working standards necessary or requested by the Regulatory Authority for obtaining the Marketing Authorization or any other registration. In addition, Galena shall provide Teva with samples, free of charge, in quantities and timeline to be agreed between the parties for promotional purposes. If the parties mutually agree that additional samples are needed after the Marketing Authorization is granted, Galena shall supply Teva with such samples, at Teva’s expense. If samples are required due to changes initiated by Galena, Galena shall supply Teva with the samples at no extra charge. Galena shall ensure that each delivery of Product supplied to Teva has a minimum shelf life remaining at the time of delivery equivalent to at least: (a) [***]% of its registered shelf-life; or (b) a minimum of [***] years, or as otherwise agreed in writing between the parties from time to time.
5.11 In the event that Galena is unable to supply Manufacturer's Shortfall or its failure to supply Manufacturer's Shortfall in accordance with Product for a continuous period of six (6) months after the terms confirmed date of this Agreementdelivery, Russell shall have the right to purchase xx xxxxnt of yarn equal to the Manufacturer's Shortfall from a third party. In this event, Russell's obligation to purchase the Annual Xxxxxxm Teva shall be reduced entitled to terminate this Agreement immediately by notice in writing to Galena. Such termination shall be without prejudice to any right available to Teva in case of termination under the amount of the Manufacturer's Shortfall and Manufacturer shall pay to Russell the Manufacturer's Shortfall Payment xxxhin thirty (30) days of receipt of written notice from Russellgoverning law.
Appears in 1 contract
Samples: License and Supply Agreement (Galena Biopharma, Inc.)