Common use of Non-Conformance Clause in Contracts

Non-Conformance. i. In the event that a Party becomes aware that the Idera Compound Delivered hereunder may have a nonfulfillment or unplanned departure of a specified requirement from documented GxP procedures, instructions, requirements, filed specifications, or processes (“Non-Conformance”), despite testing and quality assurance activities, then such Party will notify the other Party’s relevant Quality contact set forth in Attachment C (or as updated) within [**] Business Days of becoming aware of the Non-Conformance. Idera and AbbVie will investigate any Non-Conformance as set forth in Section 6(b)(ii) (Investigations) below and any discrepancy between the Parties regarding the determination of Non-Conformance shall escalated per each of the Party’s respective quality system requirements. AbbVie shall determine whether a shipment of the Idera Compound (or portion thereof) has a Non-Conformance at the time of Delivery within [**] days after the date of Delivery of such Idera Compound (or portion thereof). Any Idera Compound not rejected by written notice to Idera within [**] days of AbbVie’s receipt shall be deemed accepted, except for Idera Compound that is found later to have had latent defect(s) that were not reasonably discoverable within [**] days after receipt of Delivery of such Idera Compound. In the event that any proposed or actual shipment of the Idera Compound (or portion thereof) will be agreed or otherwise determined to have a Non-Conformance at the time of Delivery to AbbVie, then unless otherwise agreed to by the Parties in writing, Idera will use commercially reasonable efforts to replace such Idera Compound as is found to have a Non-Conformance as soon as reasonably practical and at no cost to AbbVie. Any Idera Compound not rejected by written notice to Idera within [**] days of AbbVie’s receipt shall be deemed accepted, except for Idera Compound that is found later to have had latent defect(s) that were not reasonably discoverable within [**] days after receipt of Delivery of such Idera Compound.

Non-Conformance. i. (a) In the event that a either Party becomes aware that the Idera Compound Delivered hereunder any Compounds may have a nonfulfillment or unplanned departure of a specified requirement from documented GxP procedures, instructions, requirements, filed specifications, or processes (“Non-Conformance”), despite any testing and quality assurance activitiesactivities (including any activities conducted by the Parties under Section 12.7 (After Manufacturer’s Release)), then such Party will shall immediately notify the other Party’s relevant Quality contact set forth Party in Attachment C (or as updated) within [**] Business Days of becoming aware accordance with the procedures of the Non-ConformanceClinical Quality Agreement. Idera and AbbVie will The Parties shall investigate any Non-Conformance as set forth in accordance with Section 6(b)(ii) 12.10 (Investigations) below and any discrepancy between the Parties regarding the determination of Non-Conformance shall escalated per each of the Party’s respective quality system requirements. AbbVie shall determine whether a shipment of the Idera Compound (or portion thereof) has a Non-Conformance at the time of Delivery within [**] days after the date of Delivery of such Idera Compound (or portion thereof). Any Idera Compound not rejected by written notice to Idera within [**] days of AbbVie’s receipt them shall be deemed accepted, except for Idera Compound that is found later to have had latent defect(sresolved in accordance with Section 12.9 (Resolution of Discrepancies). (b) that were not reasonably discoverable within [**] days after receipt of Delivery of such Idera Compound. In the event that any proposed or actual shipment of the Idera SpringWorks Compound (or portion thereof) will shall be agreed or otherwise determined to have a Non-Conformance at the time of Delivery to AbbVieGSK, then unless otherwise agreed to by the Parties, SpringWorks shall replace such SpringWorks Compound as is found to have a Non-Conformance. Unless otherwise agreed to by the Parties in writing, Idera will use commercially reasonable efforts the sole and exclusive remedies of GSK with respect to any SpringWorks Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such SpringWorks Compound as set forth in this Section 12.8(b), and (ii) indemnification under Article 22 (to the extent applicable) and (iii) termination of this Agreement pursuant to Section 24.2 (to the extent applicable, but subject to the applicable cure periods set forth therein), provided that, for clarity, GSK shall not be deemed to be waiving any of its rights to recall Compounds in accordance with the Clinical Quality Agreement. In the event that SpringWorks Compound is lost or damaged by GSK after Delivery, SpringWorks shall provide additional SpringWorks Compound (if available for the Sub-Study) to GSK; provided that GSK shall reimburse SpringWorks for the actual cost of such replaced SpringWorks Compound without markup. (c) GSK shall be responsible for, and SpringWorks shall have no obligations or liability with respect to, any GSK Compound supplied hereunder that is found to have a Non-Conformance. GSK shall replace such Idera any GSK Compound as is found to have a Non-Conformance as soon as reasonably practical Conformance. Unless otherwise agreed to by the Parties in writing, the sole and at no cost exclusive remedies of SpringWorks with respect to AbbVie. Any Idera Compound not rejected by written notice to Idera within [**] days of AbbVie’s receipt shall be deemed accepted, except for Idera any GSK Compound that is found later to have had latent defect(s) that were not reasonably discoverable within [**] days after receipt a Non-Conformance at the time of Delivery shall be (i) replacement of such Idera CompoundGSK Compound as set forth in this Section 12.8(c) and (ii) indemnification under Article 22 (to the extent applicable).

Non-Conformance. i. (a) In the event that a either Party becomes aware that the Idera any Compound Delivered hereunder may have a nonfulfillment or unplanned departure of a specified requirement from documented GxP procedures, instructions, requirements, filed specifications, or processes (“Non-Conformance”), despite testing and quality assurance activitiesactivities (including any activities conducted by the Parties under Section 8.8.1), then such Party will shall immediately notify the other Party’s relevant Quality contact set forth Party in Attachment C (or as updated) within [**] Business Days of becoming aware accordance with the procedures of the Non-ConformanceClinical Quality Agreement. Idera and AbbVie will The Parties shall investigate any Non-Conformance as set forth in accordance with Section 6(b)(ii) 8.9 (Investigations) below and any discrepancy between the Parties regarding the determination of Non-Conformance shall escalated per each of the Party’s respective quality system requirements. AbbVie shall determine whether a shipment of the Idera Compound (or portion thereof) has a Non-Conformance at the time of Delivery within [**] days after the date of Delivery of such Idera Compound (or portion thereof). Any Idera Compound not rejected by written notice to Idera within [**] days of AbbVie’s receipt them shall be deemed accepted, except for Idera Compound that is found later to have had latent defect(sresolved in accordance with Section 8.8.3. (b) that were not reasonably discoverable within [**] days after receipt of Delivery of such Idera Compound. In the event that any proposed or actual shipment of the Idera MSD Compound (or portion thereof) will shall be agreed to have a Non-Conformance at the time of Delivery to Company, then unless otherwise agreed to by the Parties, MSD shall, at its own expense, replace such MSD Compound as is found to have a Non-Conformance (with respect to MSD Compound that has not yet been administered in the course of performing the Study). Unless otherwise agreed to by the Parties in writing, the sole and exclusive remedies of Company with respect to any MSD Compound that is found to have a Non-Conformance at the time of Delivery shall be [***]. In the event MSD Compound is lost or otherwise damaged by Company after Delivery, MSD shall [***]; provided, that, [***]. Except as set forth in the foregoing sentence, MSD shall have [***] for any MSD Compound supplied hereunder other than such MSD Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to AbbVieCompany. (c) Company shall be responsible for, then unless otherwise agreed and MSD shall have no obligation or liability with respect to, any Company Compound supplied hereunder that is found to by the Parties in writinghave a Non-Conformance. Company shall, Idera will use commercially reasonable efforts to at its own expense, replace such Idera any Company Compound as is found to have a Non-Conformance as soon as reasonably practical (with respect to Company Compound that has not yet been administered in the course of performing the Study). Unless otherwise agreed to by the Parties in writing, the sole and at no cost exclusive remedies of MSD with respect to AbbVie. Any Idera Compound not rejected by written notice to Idera within [**] days of AbbVie’s receipt shall be deemed accepted, except for Idera any Company Compound that is found later to have had latent defect(s) that were not reasonably discoverable within a Non-Conformance at the time of Delivery shall be [***] days after receipt of Delivery of such Idera Compoundprovided that, for clarity, MSD shall not be deemed to be waiving any rights under Section 8.15.

Non-Conformance. i. (a) In the event that a either Party becomes aware that the Idera Compound Delivered hereunder any Compounds may have a nonfulfillment or unplanned departure of a specified requirement from documented GxP procedures, instructions, requirements, filed specifications, or processes (“Non-Non- Conformance”), despite any testing and quality assurance activitiesactivities (including any activities conducted by the Parties under Section 12.11 (After Manufacturer’s Release)), then such Party will shall immediately notify the other Party’s relevant Quality contact set forth Party in Attachment C (or as updated) within [**] Business Days of becoming aware accordance with the procedures of the Non-ConformanceClinical Quality Agreement. Idera and AbbVie will The Parties shall investigate any Non-Conformance as set forth in accordance with Section 6(b)(ii) 12.14 (Investigations) below and any discrepancy between the Parties regarding the determination of Non-Conformance shall escalated per each of the Party’s respective quality system requirements. AbbVie shall determine whether a shipment of the Idera Compound (or portion thereof) has a Non-Conformance at the time of Delivery within [**] days after the date of Delivery of such Idera Compound (or portion thereof). Any Idera Compound not rejected by written notice to Idera within [**] days of AbbVie’s receipt them shall be deemed accepted, except for Idera Compound that is found later to have had latent defect(sresolved in accordance with Section 12.13 (Resolution of Discrepancies). (b) that were not reasonably discoverable within [**] days after receipt of Delivery of such Idera Compound. In the event that any proposed or actual shipment of the Idera SpringWorks Compound (or portion thereof) will be is agreed or otherwise determined to have a Non-Conformance at the time of Delivery to AbbVieGSK, then unless otherwise agreed to by the Parties, SpringWorks shall replace such SpringWorks Compound as is found to have a Non-Conformance. Unless otherwise agreed to by the Parties in writing, Idera will use commercially reasonable efforts the sole and exclusive remedies of GSK with respect to replace such Idera any SpringWorks Compound as that is found to have a Non-Non- Conformance as soon as reasonably practical and at no cost to AbbVie. Any Idera Compound not rejected by written notice to Idera within [**] days the time of AbbVie’s receipt Delivery shall be (i) replacement of such SpringWorks Compound as set forth in this Section 12.12(b), and (ii) indemnification under Article 22 (to the extent applicable) and (iii) termination of this Agreement pursuant to Section 24.2 (to the extent applicable, but subject to the applicable cure periods set forth therein), provided that, for clarity, GSK shall not be deemed acceptedto be waiving any of its rights to recall Compounds in accordance with the Clinical Quality Agreement. In the event that SpringWorks Compound is lost or damaged by GSK after Delivery, except for Idera SpringWorks shall use Commercially Reasonable Efforts to provide additional SpringWorks Compound to GSK; provided that GSK shall (c) GSK shall be responsible for, and SpringWorks shall have no obligations or liability with respect to, any GSK BCMA Product that is found later to have had latent defect(s) that were not reasonably discoverable within [**] days after receipt of Delivery of such Idera Compounda Non- Conformance.

Non-Conformance. i. (a) In the event that a either Party becomes aware that the Idera any Compound Delivered hereunder may have a nonfulfillment or unplanned departure of a specified requirement from documented GxP procedures, instructions, requirements, filed specifications, or processes (“Non-Conformance”), despite testing and quality assurance activitiesactivities (including any activities conducted by the Parties under Sections 8.7.1 (After Manufacturer’s Release)), then such Party will shall immediately notify the other Party’s relevant Quality contact set forth Party in Attachment C (or as updated) within [**] Business Days of becoming aware accordance with the procedures of the Non-ConformanceClinical Quality Agreements. Idera and AbbVie will The Parties shall investigate any Non-Conformance as set forth in accordance with Section 6(b)(ii) 8.9 (Investigations) below and any discrepancy between the Parties regarding the determination of Non-Conformance shall escalated per each of the Party’s respective quality system requirements. AbbVie shall determine whether a shipment of the Idera Compound (or portion thereof) has a Non-Conformance at the time of Delivery within [**] days after the date of Delivery of such Idera Compound (or portion thereof). Any Idera Compound not rejected by written notice to Idera within [**] days of AbbVie’s receipt them shall be deemed accepted, except for Idera Compound that is found later to have had latent defect(sresolved in accordance with Section 8.8 (Resolution of Discrepancies). (b) that were not reasonably discoverable within [**] days after receipt of Delivery of such Idera Compound. In the event that any proposed or actual shipment of the Idera Alliance Compound (or portion thereof) will shall be agreed to have a Non-Conformance at the time of Delivery to Syndax or during the shelf life set forth in Section 8.2 (in either case, a “Non-Conformance Event”), then unless otherwise agreed to by the Parties, the Alliance shall replace such Alliance Compound as is found to have a Non-Conformance (with respect to Alliance Compound that has not yet been administered in the course of performing the Study). Unless otherwise agreed to by the Parties in writing, the sole and exclusive remedies of Syndax with respect to any Alliance Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Alliance Compound as set forth in this Section 8.7.2(b), (ii) indemnification under Section 14.2 (to the extent applicable) and (iii) termination of this Agreement pursuant to Section 6.3 (to the extent applicable, but subject to the applicable cure periods set forth therein); provided, for clarity, that Syndax shall not be deemed to be waiving any rights under Section 8.15. In the event that Alliance Compound is lost or damaged after Delivery, the Alliance may provide additional Alliance Compound to Syndax, if available for the Study. Such replaced Alliance Compound shall ***, so long as the amount replaced *** (the “Replacement Threshold”). Syndax shall pay the Alliance the Manufacturing Costs per vial of any replaced Alliance Compound which the Alliance agrees to supply ***. For the avoidance of doubt, the Alliance shall have no obligation to provide replacement Alliance Compound for any Alliance Compound supplied hereunder other than such Alliance Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to AbbVie, then unless otherwise agreed to by the Parties in writing, Idera will use commercially reasonable efforts to replace such Idera Compound as is found to have a Non-Conformance as soon as reasonably practical and at no cost to AbbVieSyndax. Any Idera Compound not rejected by written notice to Idera within [**] days of AbbVie’s receipt The Alliance shall be deemed accepted, except responsible for Idera any costs incurred by Syndax in connection with the return or destruction of any Alliance Compound that is found later to have had latent defect(s) that were not reasonably discoverable within [**] days after receipt of Delivery of such Idera Compound.supplied

Non-Conformance. i. a. In the event that a either Party becomes aware that the Idera any Compound Delivered hereunder may have a nonfulfillment or unplanned departure of a specified requirement from documented GxP procedures, instructions, requirements, filed specifications, or processes (“Non-Conformance”), despite testing and quality assurance activitiesactivities (including any activities conducted by the Parties under Sections 8.7.1 (After Manufacturer's Release)), then such Party will shall notify the other Party’s relevant Quality contact set forth in Attachment C (or as updated) within [**] Business Days of becoming aware Party upon identification of the Non-Conformance. Idera and AbbVie will The Parties shall investigate any Non-Conformance as set forth in accordance with Section 6(b)(ii) 8.9 (Investigations) below and any discrepancy between the Parties regarding the determination of Non-Conformance shall escalated per each of the Party’s respective quality system requirements. AbbVie shall determine whether a shipment of the Idera Compound (or portion thereof) has a Non-Conformance at the time of Delivery within [**] days after the date of Delivery of such Idera Compound (or portion thereof). Any Idera Compound not rejected by written notice to Idera within [**] days of AbbVie’s receipt them shall be deemed accepted, except for Idera Compound that is found later to have had latent defect(s) that were not reasonably discoverable within [**] days after receipt resolved in accordance with Section 8.8 (Resolution of Delivery of such Idera Compound. Discrepancies). b. In the event that any proposed or actual shipment of the Idera Menarini Compound (or portion thereof) will shall be agreed to have a Non-Conformance at the time of Delivery to Context, then unless otherwise agreed to by the Parties, Menarini shall promptly replace such Menarini Compound as is found to have a Non-Conformance (with respect to Menarini Compound that has not yet been administered in the course of performing the Study). Unless otherwise agreed to by the Parties in writing, the sole and exclusive remedies of Context with respect to any Menarini Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) prompt replacement of such Menarini Compound as set forth in this Section 8.7.2(b), and (ii) indemnification under Section 14.2 (to the extent applicable); provided, for clarity, that Context shall not be deemed to be waiving any rights under Section 8.15. In the event that Menarini Compound is lost or otherwise damaged after Delivery, the Parties shall discuss a replacement supply at reasonable cost (which shall not exceed Menarini’s direct cost of goods of the Menarini Compound, including shipment costs plus [***]) and reasonable timelines. For the avoidance of doubt, Menarini shall have no obligation to provide replacement Menarini Compound for any Menarini Compound supplied hereunder other than such Menarini Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to AbbVieContext. Menarini shall be responsible for any costs incurred by Context in connection ACTIVE/117982251.1 with the return or destruction of any Menarini Compound supplied hereunder that is found to have a Non-Conformance caused by Menarini. c. Context shall be responsible for, then unless otherwise agreed and Menarini shall have no obligations or liability with respect to, any Context Compound supplied hereunder that is found to by the Parties in writing, Idera will use commercially reasonable efforts to have a Non-Conformance. Context shall replace such Idera any Context Compound as is found to have a Non-Conformance as soon as reasonably practical (with respect to Context Compound that has not yet been administered in the course of performing the Study). Unless otherwise agreed to by the Parties in writing, the sole and at no cost exclusive remedies of Menarini with respect to AbbVie. Any Idera Compound not rejected by written notice to Idera within [**] days of AbbVie’s receipt shall be deemed accepted, except for Idera any Context Compound that is found later to have had latent defect(s) that were not reasonably discoverable within [**] days after receipt a Non-Conformance at the time of Delivery shall be (i) replacement of such Idera CompoundContext Compound as set forth in this Section 8.7.2(c), and (ii) indemnification under Section 14.2 (to the extent applicable); provided, for clarity, that Menarini shall not be deemed to be waiving any rights under Section 8.15.