Common use of Failure to Supply Clause in Contracts

Failure to Supply. A failure to supply (a "Failure to Supply") shall occur if after the date hereof, (A) there occurs a pre-commercialization audit failure in accordance with Section 3.2 hereof, or (B) there occurs a post-commercialization audit and inspection failure in accordance with Section 3.3 hereof, or (C) the parties are unable or unwilling or have failed for any reason to agree on the initial Specifications 6 months after submission of the Market Requirements in accordance with Section 4.1 hereof, or (D) for a period of or exceeding 60 days Genetronics is unable or unwilling or has failed for any reason (including the occurrence of a Force Majeure Event as defined in Section 11.6, or following commencement of a case by or against Genetronics under the Bankruptcy Code (as defined in Section 11.7)) to supply to Ethicon 85% or more of any Products in compliance with the desired delivery date specified in the purchase orders submitted by Ethicon in accordance with Section 5.3, or (E) there occurs an Event of Default which is caused by Genetronics and Ethicon elects not to terminate this Agreement pursuant to Section 11.5; and thereafter such Failure to Supply is not cured by Genetronics within 30 days after receipt of written notice from Ethicon. After the occurrence of a Failure to Supply, (i) Ethicon may make and have made the Products pursuant to the license granted in Section 7.1 above, (ii) Ethicon shall have no obligation to purchase any further Products from Genetronics hereunder, (iii) Genetronics shall instruct the Escrow Agent to make available to Ethicon or its designee the contents of the Escrow Account, (iv) Genetronics shall provide such assistance, training and other information as shall be necessary in order for Ethicon or its designated supplier to manufacture or have manufactured the Products, and (v) Ethicon

Failure to Supply. A failure (a) Notwithstanding Section 15.4 and subject to supply (the Agreed Capacity Levels, if a "Failure to Supply") shall occur if after the date hereof, (A) there occurs a pre-commercialization audit failure in accordance with Section 3.2 hereof, or (B) there occurs a post-commercialization audit and inspection failure in accordance with Section 3.3 hereof, or (C) the parties are unable or unwilling or have failed for any reason to agree on the initial Specifications 6 months after submission of the Market Requirements in accordance with Section 4.1 hereof, or (D) for a period of or exceeding 60 days Genetronics is unable or unwilling or has failed for any reason (including the occurrence of a Force Majeure Event as defined in Section 11.6, or following commencement of a case by or against Genetronics under the Bankruptcy Code (as defined in Section 11.7)) to supply to Ethicon 85% or more of any Products in compliance with the desired delivery date specified in the purchase orders submitted by Ethicon in accordance with Section 5.3, or (E) there occurs an Event of Default which is caused by Genetronics and Ethicon elects not to terminate this Agreement pursuant to Section 11.5; and thereafter such Failure to Supply is not cured by Genetronics within 30 days after receipt of written notice from Ethicon. After the occurrence of a Failure to Supply, CM (i) Ethicon may make and have made the Products pursuant is unable to the license granted in Section 7.1 abovesupply its full Allocation of INHALE's requirements [**], unless such failure results from an action or inaction by INHALE, (ii) Ethicon shall have no obligation has [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. declined or failed to purchase implement any further Products from Genetronics hereunderchanges to the Manufacturing Requirements or DMR, or (iii) Genetronics shall instruct has declined or failed to add additional manufacturing capacity for the Escrow Agent Devices, Base Units, Transjectors and Xxxxxxxx, reasonably requested by INHALE and consistent with the long term marketing data reviewed by the Steering Committee pursuant to make available Section 2.1(c)(iii), [**] (b) Notwithstanding Section 15.4 and subject to Ethicon the Agreed Capacity Levels, if a CM (i) is not able to manufacture and supply its full Allocation of INHALE's requirements for Devices, Base Units, Transjectors and Xxxxxxxx [**] unless such failure results from an action or its designee the contents of the Escrow Accountinaction by INHALE, (ivii) Genetronics has declined or failed to implement any changes to the Manufacturing Requirements or DMR, or (iii) has declined or failed to add additional manufacturing capacity for the Devices, Base Units, Transjectors and Xxxxxxxx, reasonably requested by INHALE and consistent with the long term marketing data reviewed by the Steering Committee pursuant to Section 2.1(c)(iii), [**] (c) [**] [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. [**] Such supply shall provide such assistanceotherwise be subject to the terms and conditions of this Agreement. (d) [**]), training the defaulting CM shall meet the obligations in Sections 3.5(b) and other information as shall be necessary 14.4(b) (to the extent it has not already done so) during the period set forth in order for Ethicon or its designated supplier to manufacture or have manufactured the ProductsSection 4.8(c), and (v) Ethicon[**]

Failure to Supply. A failure 4.1 In the event MD Xxxxxxxx is not able to supply, or reasonably anticipates that it will not be able to supply, any Services under any Work Order for any reason, including without limitation force majeure according to Section 11.8, MD Xxxxxxxx shall (i) without undue delay provide a written notice (e-mail is sufficient) to Bellicum stating in reasonable detail the cause of such supply inability and the proposed remedial measures and the date such inability is expected to end, and (ii) use commercially reasonable efforts to supply such Services as soon as practicable. The Parties will discuss in good faith all appropriate means of resolving such supply problems. 4.2 In the event that MD Xxxxxxxx is unable to Manufacture and release three (3) consecutive Patient Lots of the same Deliverable or a "Failure total of six (6) Patient Lots of the same Deliverable in any rolling twelve (12) month period as required under a Work Order (excluding, in both circumstances, any Deliverables impacted by Process Inherent Issues), provided all Bellicum Obligations have been successfully met including timely delivery of the Materials to Supply"MD Xxxxxxxx, then a supply interruption shall be deemed to have occurred (“Supply Interruption”). Provided that such Supply Interruption is not (a) shall occur if after the date hereofcaused by force majeure according to Section 11.8, (Ab) there occurs due to the fault of Bellicum or any Third Party, or (c) due to any Process Inherent Issue, a pre-commercialization audit supply failure shall be deemed to have occurred (“Supply Failure”). In the event of a Supply Failure, MD Xxxxxxxx shall, within sixty (60) calendar days from the beginning of the Supply Failure, prepare an action plan setting forth a proposal to determine the root cause of the Supply Failure and the corrective actions to be taken (the “Action Plan”). The Action Plan shall then be presented to the JSC within such sixty (60) day period. The JSC may accept, modify or reject such Action Plan. In the event the JSC cannot agree upon the proposed (or modified) Action Plan within fourteen (14) days, the matter shall be escalated to the senior management of the Parties in accordance with Section 3.2 hereof10.2. If senior management, or acting in good faith, cannot agree on an Action Plan within forty-five (B45) there occurs days from the date of its referral to senior management, then MD Xxxxxxxx shall have the right to terminate this Agreement upon fifteen (15) days notice. 4.3 Upon determination that a post-commercialization audit Supply Failure has occurred and inspection failure is incapable of being cured within sixty (60) days from the date it is deemed a Supply Failure, the Term of such applicable Work Order, as it related to such specific Deliverable, shall be automatically extended for the length of such Supply Failure (unless otherwise terminated in accordance with Section 3.3 hereof4.2). For the avoidance of doubt, or the length of the Supply Failure arising from the failure to Manufacture and release three (C3) consecutive Patient Lots of the parties are unable or unwilling or have failed for any reason to agree same Deliverable, shall commence on the initial Specifications 6 months after submission date of the Market Requirements in accordance with Section 4.1 hereof, or (D) for a period of or exceeding 60 days Genetronics is unable or unwilling or has first failed for any reason (including Patient Lot and conclude on the occurrence of a Force Majeure Event as defined in Section 11.6, or following commencement of a case by or against Genetronics under the Bankruptcy Code (as defined in Section 11.7)) to supply to Ethicon 85% or more of any Products in compliance with the desired delivery date specified in the purchase orders submitted by Ethicon in accordance with Section 5.3, or (E) there occurs an Event of Default which is caused by Genetronics and Ethicon elects not to terminate this Agreement pursuant to Section 11.5; and thereafter such Failure to Supply is not cured by Genetronics within 30 days after receipt of written notice from Ethicon. After the occurrence of a Failure to Supply, (i) Ethicon may make and have made the Products pursuant to the license granted in Section 7.1 above, (ii) Ethicon shall have no obligation to purchase any further Products from Genetronics hereunder, (iii) Genetronics shall instruct the Escrow Agent to make available to Ethicon or its designee the contents successful implementation of the Escrow Account, (iv) Genetronics shall provide such assistance, training and other information as shall be necessary in order for Ethicon or its designated supplier to manufacture or have manufactured the ProductsAction Plan, and the length of the Supply Failure arising from the failure to Manufacture and release a total of six (v6) EthiconPatient Lots of the same Deliverable in any rolling twelve (12) month period, shall commence on the date of the last failed Patient Lot and conclude on the successful implementation of the Action Plan.