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.
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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) If a delay due Shortage arises or Bachem becomes aware of an anticipated Shortage, Bachem shall notify Apellis in writing within [**], setting forth the underlying reasons for such Shortage (e.g., available quantities of Materials, Manufacturing capacity or other resources needed in the Manufacture of Drug Substance), proposed remedial measures, and the date such Shortage is expected to a shortage in supply of usable active pharmaceutical ingredient or any other manufacturing material supplied by a third party through no fault of Ethypharmend. Bachem shall use Commercially Reasonable Efforts to end the Shortage at its sole cost, provided that such Shortage was determined to be solely within Bachem’s control.
(b) If Bachem is unable to supply any Drug Substance subject to a material breach Firm Order submitted by Apellis within [**] after its initial failure to supply measured from the relevant Delivery Date (and in the amount specified in Section 3.4) or the expiration of this Agreement by Ampio for which Ethypharm has provided written notice thereof the Replenishment Period (as defined in Section 2.6(b)), as applicable), then Bachem shall consult with Apellis and the Parties shall work together to Ampio or remedy the Shortage at Bachem’s expense.
(c) a Force Majeure Event. During a Supply Interruption, Ampio, shall be entitled If Bachem is unable to claim from Ethypharm a penalty remedy the Shortage after an aggregate period 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 longer as agreed in writing by the Parties Parties), commencing with the date upon which such failure to supply began (as specified in Section 2.5(b)) (a “Supply Interruption”), then Apellis shall have the right to: (i) cancel any outstanding Firm Order until the Supply Interruption has been rectified, and subject Apellis shall have no obligation to appropriate confidentiality agreements being entered into Bachem for any Firm Order of the Drug Substance to the extent the Drug Substance has not been supplied as of the date of delivery of such cancelation notice; and/or (ii) have the Drug Substance manufactured by an Approved Manufacturer rather than by Bachem. Apellis may continue to use the Approved Manufacturer to supply the Drug Substance until Bachem notifies Apellis that it is again able to supply at least [**]% of Apellis’ requirements for the Drug Substance and substantiates such claim to Apellis’ reasonable satisfaction. Upon such a showing, Apellis shall commence purchasing from Bachem at least [**]% of Apellis’s requirements for such Drug Substance, provided that: (1) Apellis shall not be required to cancel any then outstanding purchase orders with the Approved Manufacturer to the extent such orders have been accepted by such third partyApproved Manufacturer and are binding obligations of Apellis and (2) Bachem shall pay all cancellation costs incurred by Apellis in switching its purchases from such Approved Manufacturer to Bachem. Apellis shall use Commercially Reasonable Efforts to avoid significant cancellation fees in any contracts it enters with an Approved Manufacturer. Apellis shall not order Drug Substances from an Approved Manufacturer for delivery more than [**] following the date of such order.
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Samples: Commercial Supply Agreement (Apellis 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.
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Samples: License and Supply Agreement (Galena Biopharma, Inc.)
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.
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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 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.
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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.
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