MATERIAL SUPPLY BREACH definition

MATERIAL SUPPLY BREACH means a failure of BI Austria: (a) to supply to InterMune at least [ * ] of InterMune's binding forecasted requirements of PRODUCT (or actual orders, if less) that are due for delivery by the designated delivery date during the then-current calendar quarter; or (b) to repeatedly [ * ] materially violate against cGMP, as described in Sections 5.6 and 5.7.

MATERIAL SUPPLY BREACH means a failure of BI RCV: (a) to supply to VIDARA at *** of VIDARA’s binding forecasted requirements of PRODUCT (or actual orders, if less) that are due for delivery by the designated delivery date during the then-current calendar quarter; or (b) to repeatedly *** materially violate against cGMP.

MATERIAL SUPPLY BREACH means: DOTTIKON's falling more than [ *** ] behind its schedule for its Manufacturing campaign with respect to any Purchase Order submitted by PCYC and accepted by DOTTIKON pursuant to Section 3.4, as such schedule is provided to PCYC pursuant to Section 3.4.3; or DOTTIKON's failure to supply to PCYC at least [ *** ] of the quantity of Acceptable Product set forth in any Purchase Order submitted to and accepted by DOTTIKON pursuant to Section 3.4 by the delivery date set forth in such Purchase Order. Except with respect to Section 13.2.2, "Material Supply Breach" shall include DOTTIKON's failure to meet such its Manufacturing obligations as described in subsection (a) or (b) above due to a Force Majeure Event.

Examples of MATERIAL SUPPLY BREACH in a sentence

• If InterMune is not reasonably satisfied that BI Austria will be able to avoid such MATERIAL SUPPLY BREACH, then InterMune shall forward this issue to the STEERING COMMITTEE to determine whether it is necessary or desirable to establish a second source manufacturer in accordance with Section 3.7.

• Upon receipt of such notice, the Parties shall promptly confer to discuss the circumstances and magnitude of such potential MATERIAL SUPPLY BREACH, and to determine in good faith whether there are any reasonable steps that BI Austria could take to avoid such MATERIAL SUPPLY BREACH.

• In the event of a MATERIAL SUPPLY BREACH, the matter of second source manfacture of DRUG SUBSTANCE and/or PRODUCT CONFIDENTIAL XxxX: 151373 and any potential next steps shall be discussed in good faith by the Parties’ executive officers, subject to the remainder of this Section 4.9.

• Upon receipt of such notice, the Parties shall promptly confer to discuss the circumstances and magnitude of such potential MATERIAL SUPPLY BREACH, and to determine in good faith whether there are any reasonable steps that BI RCV could take to avoid such MATERIAL SUPPLY BREACH.

• If HORIZON is not reasonably satisfied that BI will be able to avoid such MATERIAL SUPPLY BREACH, then HORIZON shall forward this issue to the STEERING COMMITTEE to determine whether it is necessary or desirable to establish a second source manufacturer to prevent such a MATERIAL SUPPLY BREACH from occurring.

More Definitions of MATERIAL SUPPLY BREACH

MATERIAL SUPPLY BREACH means a failure of Lynx to supply at least [REDACTED] of Xxxxxxx Pharma's and its Affiliates' binding forecasted requirements, pursuant to Article 6 hereof, of Products for use in the Field (or actual orders, if less) for delivery in the immediately preceding calendar quarter, and at least [REDACTED] of Xxxxxxx Pharma's and its Affiliates' binding forecasted requirements of Products (or actual orders, if less) that are due for delivery up to such date during the current calendar quarter; provided, however, that any such failure shall not constitute a Material Supply Breach if such failure is caused by an event of force majeure.

MATERIAL SUPPLY BREACH means a failure of Biocircuits to supply, for reasons other than force majeure, any Instruments, Cartridges and/or Accessories to Becton, pursuant to purchase orders accepted by Biocircuits, for a period of at least [**] days from the date specified for delivery of such Instruments, Cartridges and/or Accessories in such accepted Becton purchase orders.

MATERIAL SUPPLY BREACH means a failure of NeoRx to supply at least [ * ] of Xxxxxxx Pharma's binding orders for Drug Product pursuant to Section 6.4 for delivery during the immediately preceding [ * ], unless such failure is caused by Force Majeure.

MATERIAL SUPPLY BREACH means: LONZA's falling more than [ *** ] behind its schedule for its Manufacturing campaign with respect to any Purchase Order submitted by PCYC and accepted by LONZA pursuant to Section 3.4, as such schedule is provided to PCYC pursuant to Section 3.4.3; or LONZA's failure to supply to PCYC at least [ *** ] of the quantity of Acceptable Product set forth in any Purchase Order submitted to and accepted by LONZA pursuant to Section 3.4 by the delivery date set forth in such Purchase Order.

MATERIAL SUPPLY BREACH means: DIXIE's falling more than [ *** ] behind its schedule for its Manufacturing campaign with respect to any Purchase Order submitted by PCYC and accepted by XXXXX pursuant to Section 3.4, as such schedule is provided to PCYC pursuant to Section 3.4.3; or DIXIE's failure to supply to PCYC at least [ *** ] of the quantity of Acceptable Product set forth in any Purchase Order submitted to and accepted by XXXXX pursuant to Section 3.4 by the delivery date set forth in such Purchase Order.

MATERIAL SUPPLY BREACH means, on a Drug Product-by-Drug Product basis, a failure of Contractor to supply to PCYC both (a) at least [***] of PCYC's binding forecasted requirements of such Drug Product (or actual orders placed pursuant to Section 3.4, if less) that are due for delivery during the then-current calendar quarter; and (b) at least [***] of PCYC's binding forecasted requirements for such Drug Product pursuant to Section 3.3.2 (or actual orders placed pursuant to Section 3.4, if less) for delivery in the immediately preceding calendar quarter. Solely for purposes of Section 3.7.2, but for no other purpose hereunder, "Material Supply Breach" shall include Contractor's failure to supply such Drug Product as described in the preceding sentence due to a Force Majeure Event (as defined in Article 13); provided, however, that no Material Supply Breach shall be deemed to have occurred in the event that Contractor's failure to supply such Drug Product as described in (a) or (b) above is a direct result of the failure of PCYC or its designated suppliers to supply conforming API or other PCYC Components within the time period required for Contractor's timely Manufacture hereunder.

MATERIAL SUPPLY BREACH shall include Contractor's failure to supply such Drug Product as described in the preceding sentence due to a Force Majeure Event (as defined in Article 13); provided, however, that no Material Supply Breach shall be deemed to have occurred in the event that Contractor's failure to supply such Drug Product as described in (a) or (b) above is a direct result of the failure of PCYC or its designated suppliers to supply conforming API or other PCYC Components within the time period required for Contractor's timely Manufacture hereunder.