Common use of Supply Interruption Clause in Contracts

Supply Interruption. A “Supply Interruption” shall be deemed to have occurred if Ampio has not received ordered Product for more than sixty (60) days past the scheduled and agreed upon due delivery date (“Due Delivery Date”) and Ampio holds no saleable stock of the Product after attempting to maintain at least four (4) months of sealable stock through binding orders made pursuant to Section 4.3 (subject to Ethypharm’s delivery thereof), unless such Supply Interruption is caused by (a) a delay due to a shortage in supply of usable active pharmaceutical ingredient or any other manufacturing material supplied by a third party through no fault of Ethypharm, (b) a material breach of this Agreement by Ampio for which Ethypharm has provided written notice thereof to Ampio or (c) a Force Majeure Event. During a Supply Interruption, Ampio, shall be entitled to claim from Ethypharm a penalty of one per cent (1%) of the amount of the late deliveries value of Product from the third week of delay, per each week of delay. The total amount of penalty to be paid by Ethypharm shall not exceed twenty per cent (20%) of the late deliveries value of Bulk Product not delivered. Such payment shall be made to Ampio within thirty (30) days date of Ampio’s invoice. Notwithstanding the other provisions of * Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission. this Agreement, if a Supply Interruption lasts for more than three (3) months, Ampio shall be permitted, at its discretion, (i) to require Ethypharm to use a different supplier for the Product, once Ampio has provided reasonable notice to Ethypharm of such requirement and/or (ii) to thereafter purchase some or all of its requirement for the Product from a third party of its choosing and Ethypharm shall grant all necessary licenses and provide all necessary and reasonable cooperation to effect such transfer to the new manufacturing site, on conditions to be agreed in writing by the Parties and subject to appropriate confidentiality agreements being entered into by such third party.

Appears in 1 contract

Samples: Manufacturing and Supply Agreement (Rosewind CORP)

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Supply Interruption. A “Supply Interruption” shall be deemed If Seller is unable to have occurred if Ampio has not received ordered Product supply Products in accordance with accepted Purchase Orders at any time for more any reason other than sixty a force majeure (60) days past the scheduled and agreed upon due delivery date (“Due Delivery Date”as hereinafter defined) and Ampio holds no saleable stock other than pursuant to a capital expenditure project jointly undertaken by Buyer and Seller (a "Supply Interruption Period"), Seller shall attempt in good faith to provide written notice to Buyer as far in advance of the commencement of the Supply Interruption Period as possible or as soon thereafter as possible and shall use commercially reasonable efforts to resume supply in a timely manner. Seller will also provide advance written notice to Buyer of any planned operational interruption relating to the Products if Seller reasonably believes that the event will result in a material interruption of supply of Products. So that all Product can be shipped as required under this Agreement, promptly after attempting to maintain at least four (4) months delivery of sealable stock through binding orders made any such notice, Buyer and Seller will in good faith negotiate an agreement pursuant to Section 4.3 (subject to Ethypharm’s delivery thereof), unless such which Buyer's anticipated needs for Products would be filled during the Supply Interruption is caused by Period. Such an agreement may include, for example, that Seller would (ai) produce a delay due sufficient amount of Products prior to a shortage in the Service Interruption Period to fulfill Buyer's anticipated needs during the Supply Interruption Period; (ii) have an Affiliate of Seller supply of usable active pharmaceutical ingredient Products or any other manufacturing material supplied by a third party through no fault of Ethypharm, (b) a material breach of Substitute Products under this Agreement by Ampio during the Supply Interruption Period to the extent Seller is unable to supply the Products in accordance herewith; and/or (iii) obtain Products or Substitute Products from a third-party manufacturer for which Ethypharm shipment to Buyer in accordance with Purchase Orders during the Supply Interruption Period. If Seller cannot or does not provide Products during a Supply Interruption Period for a consecutive period of forty-five (45) days, Buyer shall have the right to procure, if possible, Substitute Products on the open market ("cover products") on a short-term basis and on commercially reasonable terms and Seller shall reimburse Buyer for the cost of such cover products in quantities consistent with the Purchase Orders to the extent such cost exceeds the cost of the Products under this Agreement; provided, however, that once Seller has provided written notice thereof to Ampio or (c) a Force Majeure Event. During a Supply Interruption, Ampio, shall be entitled Buyer that Seller is able to claim from Ethypharm a penalty of one per cent (1%) resume supply of the amount of the late deliveries value of Product from the third week of delay, per each week of delay. The total amount of penalty to be paid by Ethypharm shall not exceed twenty per cent (20%) of the late deliveries value of Bulk Product not delivered. Such payment shall be made to Ampio within thirty (30) days date of Ampio’s invoice. Notwithstanding the other provisions of * Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities and Exchange Commission. Products under this Agreement, if Buyer will use commercially reasonable efforts to stop its procurement of cover products and will resume acquiring Products from Seller under this Agreement. If Buyer does procure cover products and Seller reimburses Buyer for any excess costs thereof in accordance with the foregoing, Seller's liability arising as a result of the Supply Interruption lasts for more than three (3) months, Ampio Period shall be permitted, at its discretion, (i) limited to require Ethypharm to use a different supplier for the Product, once Ampio has provided reasonable notice to Ethypharm of such requirement and/or (ii) to thereafter purchase some or all of its requirement for the Product from a third party of its choosing and Ethypharm shall grant all necessary licenses and provide all necessary and reasonable cooperation to effect such transfer to the new manufacturing site, on conditions to be agreed in writing by the Parties and subject to appropriate confidentiality agreements being entered into by such third partyreimbursement obligation.

Appears in 1 contract

Samples: Supply Agreement (Philipp Brothers Chemicals Inc)

Supply Interruption. A “Supply Interruption” shall will be deemed to have occurred and continuing if Galena has ordered Product from MSRx consistent with its obligations under Section 6.5 and that during a period of at least three (3) consecutive months Galena has not received at least [***] percent ([***]%) of those quantities of Product so ordered, which failure results a material disruption in Galena’s ability to Commercialize the Product in the Territory. Notwithstanding the foregoing, no Supply Interruption will be deemed to have occurred if Ampio has not received ordered the applicable purchase orders referenced above exceed [***]% of the applicable quantities of Product set forth in the forecast delivered by Galena for more than sixty the Calendar Quarter immediately preceding such purchase order and MSRx delivers [***]% of the applicable quantities. Galena will provide written notice to MSRx detailing any Supply Interruption and MSRx shall be deemed to have cured such Supply Interruption upon delivery to Galena of quantities of Product covered under such outstanding orders (60) days past the scheduled and agreed upon due delivery date (Due Delivery DateSupply Cure”) and Ampio holds no saleable stock but only for that amount which does not exceed [***]% of the applicable quantities of Product after attempting set forth in the forecast delivered by Galena for the Calendar Quarter immediately preceding such purchase order. A Supply Interruption shall be deemed ongoing until such time as MSRx affects a Supply Cure. A “Supply Outage” shall occur if, in any six (6) consecutive Agreement Months, MSRx fails to maintain meet, in at least four (4) of those months of sealable stock through binding orders made pursuant to Section 4.3 or in any two consecutive calendar months, [***] percent (subject to Ethypharm’s delivery thereof), unless such Supply Interruption is caused by (a) a delay due to a shortage in supply of usable active pharmaceutical ingredient or any other manufacturing material supplied by a third party through no fault of Ethypharm, (b) a material breach of this Agreement by Ampio for which Ethypharm has provided written notice thereof to Ampio or (c) a Force Majeure Event. During a Supply Interruption, Ampio, shall be entitled to claim from Ethypharm a penalty of one per cent (1[***]%) of the amount of actual Trade Demand for the late deliveries value of Product from In the third week of delay, per each week of delay. The total amount of penalty to be paid by Ethypharm shall event MSRx has not exceed twenty per cent (20%) of the late deliveries value of Bulk Product not delivered. Such payment shall be made to Ampio cured a Supply Outage within thirty (30) days of Galena’s written notification thereof to MSRx, MSRx shall reimburse Galena for lost Net Sales from the date of AmpioMSRx’s invoicereceipt of such written notification through the date Product is delivered under outstanding purchase orders for the Product allocated to the drug wholesalers utilized by Galena. Notwithstanding The foregoing reimbursement will be determined by calculating (x) the other provisions difference between the average daily amount of * Confidential Information indicated by Net Sales of the Product during the six (6) months immediately prior to MSRx’s receipt of Galena’s written notice of such Supply Outage and the actual amount of Net Sales during the Supply Outage, less (y) the royalty payments that would have been due to MSRx under Section 7.2 with respect to such Net Sales. Such reimbursement amount shall be paid quarterly to Galena commencing with the first month following the month in which the Supply Outage occurs, except that the maximum aggregate limit for all such reimbursement in respect of a Supply Outage during the Term shall not under any circumstances exceed [***] has been omitted from Dollars ($[***]), per occurrence with a maximum cap of [***] Dollars ($[***]). Notwithstanding anything to the contrary contained in this filing and filed separately with the Securities and Exchange Commission. this AgreementSection 2.3, if no reimbursement shall be owed to Galena for a Supply Interruption lasts for more than three (3) months, Ampio shall be permitted, at its discretion, (i) Outage where Force Majeure applies or in circumstances where the failure to require Ethypharm Supply Product is due to use acts or omissions of Galena. The reimbursement described in this Section 2.3 constitutes Galena’s exclusive remedy in the event of a different supplier for the Product, once Ampio has provided reasonable notice to Ethypharm of such requirement and/or (ii) to thereafter purchase some or all of its requirement for the Product from a third party of its choosing and Ethypharm shall grant all necessary licenses and provide all necessary and reasonable cooperation to effect such transfer to the new manufacturing site, on conditions to be agreed in writing by the Parties and subject to appropriate confidentiality agreements being entered into by such third partySupply Outage.

Appears in 1 contract

Samples: License and Supply Agreement (Midatech Pharma PLC)

Supply Interruption. A Supply of the Product is subject to availability, but ONCOVIR shall use all Commercially Reasonable Efforts to ensure supply. ONCOVIR shall take all steps to ensure clinical and commercial supply. Should ONCOVIR or a manufacturer for ONCOVIR, at any time during clinical trial development or thereafter, have reason to believe that it will be unable to meet Company’s commercially reasonable Product requirements or delivery dates, or to supply Product in accordance with a Purchase Order or otherwise meet its obligations under this Agreement (each a “Supply Interruption”), ONCOVIR shall be deemed promptly notify Company stating the reasons for the delay or failure to have occurred if Ampio has not received ordered Product for more than sixty (60) days past comply with the scheduled and agreed upon due delivery date (“Due Delivery Date”) and Ampio holds no saleable stock terms of the Product after attempting Agreement, the expected duration of the delay and the efforts ONCOVIR is taking to maintain at least four (4) months of sealable stock through binding orders made pursuant address the cause for the delay. At Company’s sole discretion ONCOVIR shall work collaboratively with Company to Section 4.3 (subject to Ethypharm’s delivery thereof), unless discuss and promptly resolve any such Supply Interruption Interruption, which efforts shall include, but shall not be limited to: providing to the extent reasonably possible in accordance with confidentiality provisions of this agreement, and at Company cost, access to ONCOVIR’s Manufacturer during Manufacturer’s regular business hours and ONCOVIR’s relevant facilities and personnel until the supply interruption is caused resolved and ensuring that any remedial actions recommended by (a) a delay due Company are considered in good faith and if accepted, promptly implemented. In addition to a shortage the rights set forth above, during any Supply Interruption, where ONCOVIR, its successors, or assigns, in supply of usable active pharmaceutical ingredient or any other manufacturing material supplied by a third party through no fault of Ethypharm, (b) a material breach of this Agreement by Ampio agreement, unjustifiably refuse or are unable to submit a purchase order to resolve the Supply Interruption for which Ethypharm has provided written notice thereof any reason, and such refusal or inability shall have continued for at least [* * *], then Company shall have the right at its sole discretion to Ampio or (c) a Force Majeure Event[* * *]. During a Supply Interruption[* * *] However, AmpioONCOVIR will provide information required for regulatory filings and will allow independent audit of its manufacturing facilities and all regulatory documentation, at the Company’s expense and subject to the manufacturer’s scheduling constraints. All such information shall be entitled to claim from Ethypharm a penalty of one per cent (1%) of the amount of the late deliveries value of Product from the third week of delay, per each week of delay. The total amount of penalty to be paid by Ethypharm shall not exceed twenty per cent (20%) of the late deliveries value of Bulk Product not delivered. Such payment shall be made to Ampio within thirty (30) days date of Ampio’s invoicetreated as ONCOVIR IP and Confidential Information. Notwithstanding the other provisions of * Confidential Information indicated by [***] has been omitted from this filing and filed separately with above, once the Securities and Exchange Commission. this Agreement, if a Supply Interruption lasts for more than three (3) months, Ampio shall be permitted, at its discretion, (i) to require Ethypharm to use a different supplier for the Product, once Ampio has provided reasonable notice to Ethypharm of such requirement and/or (ii) to thereafter purchase some or all of its requirement for the Product from a third party of its choosing and Ethypharm shall grant all necessary licenses and provide all necessary and reasonable cooperation to effect such transfer to the new manufacturing site, on conditions ceases to be agreed in writing by continuing and once ONCOVIR has re-established supply, the Parties supply, purchase and subject sale of PRODUCT under this Agreement shall resume under the direction of ONCOVIR. Company shall abandon its efforts to appropriate confidentiality agreements being entered into by such third partyseek a future supply of PRODUCT separate from ONCOVIR.

Appears in 1 contract

Samples: License and Supply Agreement (Genocea Biosciences, Inc.)

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Supply Interruption. A “Supply Interruption” shall be deemed to have occurred if Ampio has not received ordered Product for more than sixty (60) days past the scheduled and agreed upon due delivery date (“Due Delivery Date”) and Ampio holds no saleable stock of the Product after attempting to maintain at least four (4) months of sealable stock through binding orders made pursuant to Section 4.3 (subject to Ethypharm’s delivery thereof), unless such Supply Interruption is caused by (a) a delay due to a shortage in supply of usable active pharmaceutical ingredient or any other manufacturing material supplied by a third party through no fault of Ethypharm, (b) a material breach of this Agreement by Ampio for which Ethypharm has provided written notice thereof to Ampio or (c) a Force Majeure Event. During a Supply Interruption, Ampio, shall be entitled to claim from Ethypharm a penalty of one per cent (1%) of the amount of the late deliveries value of Product from the third week of delay, per each week of delay. The total amount of penalty to be paid by Ethypharm shall not exceed twenty per cent (20%) of the late deliveries value of Bulk Product not delivered. Such payment shall be made to Ampio within thirty (30) days date of Ampio’s invoice. Notwithstanding the other provisions of * Confidential Information indicated by CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***] has been omitted from this filing and filed separately with the Securities and Exchange Commission]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. this Agreement, if a Supply Interruption lasts for more than three (3) months, Ampio shall be permitted, at its discretion, (i) to require Ethypharm to use a different supplier for the Product, once Ampio has provided reasonable notice to Ethypharm of such requirement and/or (ii) to thereafter purchase some or all of its requirement for the Product from a third party of its choosing and Ethypharm shall grant all necessary licenses and provide all necessary and reasonable cooperation to effect such transfer to the new manufacturing site, on conditions to be agreed in writing by the Parties and subject to appropriate confidentiality agreements being entered into by such third party.

Appears in 1 contract

Samples: Manufacturing and Supply Agreement (Ampio Pharmaceuticals, Inc.)

Supply Interruption. A “Supply Interruption” shall will be deemed to have occurred and continuing if Galena has ordered Product from MSRx consistent with its obligations under Section 6.5 and that during a period of at least three (3) consecutive months Galena has not received at least [***] percent [***]% of those quantities of Product so ordered, which failure results a material disruption in Galena’s ability to Commercialize the Product in the Territory. Notwithstanding the foregoing, no Supply Interruption will be deemed to have occurred if Ampio has not received ordered the applicable purchase orders referenced above exceed [***]% of the applicable quantities of Product set forth in the forecast delivered by Galena for more than sixty the Calendar Quarter immediately preceding such purchase order and MSRx delivers [***]% of the applicable quantities. Galena will provide written notice to MSRx detailing any Supply Interruption and MSRx shall be deemed to have cured such Supply Interruption upon delivery to Galena of quantities of Product covered under such outstanding orders (60) days past the scheduled and agreed upon due delivery date (Due Delivery DateSupply Cure”) and Ampio holds no saleable stock but only for that amount which does not exceed [***]% of the applicable quantities of Product after attempting set forth in the forecast delivered by Galena for the Calendar Quarter immediately preceding such purchase order. A Supply Interruption shall be deemed ongoing until such time as MSRx affects a Supply Cure. A “Supply Outage” shall occur if, in any six (6) consecutive Agreement Months, MSRx fails to maintain meet, in at least four (4) of those months of sealable stock through binding orders made pursuant to Section 4.3 or in any two consecutive calendar months, [***] percent (subject to Ethypharm’s delivery thereof), unless such Supply Interruption is caused by (a) a delay due to a shortage in supply of usable active pharmaceutical ingredient or any other manufacturing material supplied by a third party through no fault of Ethypharm, (b) a material breach of this Agreement by Ampio for which Ethypharm has provided written notice thereof to Ampio or (c) a Force Majeure Event. During a Supply Interruption, Ampio, shall be entitled to claim from Ethypharm a penalty of one per cent (1[***]%) of the amount of actual Trade Demand for the late deliveries value of Product from Product. In the third week of delay, per each week of delay. The total amount of penalty to be paid by Ethypharm shall event MSRx has not exceed twenty per cent (20%) of the late deliveries value of Bulk Product not delivered. Such payment shall be made to Ampio cured a Supply Outage within thirty (30) days of Galena’s written notification thereof to MSRx, MSRx shall reimburse Galena for lost Net Sales from the date of AmpioMSRx’s invoicereceipt of such written notification through the date Product is delivered under outstanding purchase orders for the Product allocated to the drug wholesalers utilized by Galena. Notwithstanding The foregoing reimbursement will be determined by calculating (x) the other provisions difference between the average daily amount of * Net Sales of the Product during the six (6) months immediately prior to MSRx’s receipt of Galena’s written Confidential Information indicated by - . notice of such Supply Outage and the actual amount of Net Sales during the Supply Outage, less (y) the royalty payments that would have been due to MSRx under Section 7.2 with respect to such Net Sales. Such reimbursement amount shall be paid quarterly to Galena commencing with the first month following the month in which the Supply Outage occurs, except that the maximum aggregate limit for all such reimbursement in respect of a Supply Outage during the Term shall not under any circumstances exceed [***] has been omitted from Dollars ($[***]), per occurrence with a maximum cap of [***] Dollars ($[***]). Notwithstanding anything to the contrary contained in this filing and filed separately with the Securities and Exchange Commission. this AgreementSection 2.3, if no reimbursement shall be owed to Galena for a Supply Interruption lasts for more than three (3) months, Ampio shall be permitted, at its discretion, (i) Outage where Force Majeure applies or in circumstances where the failure to require Ethypharm Supply Product is due to use acts or omissions of Galena. The reimbursement described in this Section 2.3 constitutes Galena’s exclusive remedy in the event of a different supplier for the Product, once Ampio has provided reasonable notice to Ethypharm of such requirement and/or (ii) to thereafter purchase some or all of its requirement for the Product from a third party of its choosing and Ethypharm shall grant all necessary licenses and provide all necessary and reasonable cooperation to effect such transfer to the new manufacturing site, on conditions to be agreed in writing by the Parties and subject to appropriate confidentiality agreements being entered into by such third partySupply Outage.

Appears in 1 contract

Samples: License and Supply Agreement (Galena Biopharma, Inc.)

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