Non-Conformance. (a) In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Sections 8.7.1 (After Manufacturer’s Release)), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8 (Resolution of Discrepancies). (b) In the event that any proposed or actual shipment of the Merck Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to Syndax or shall otherwise be determined under the Clinical Quality Agreement to have a Non-Conformance at the time of Delivery to Syndax, then unless otherwise agreed to by the Parties, Merck shall replace such Merck Compound as is found to have a Non-Conformance (with respect to Merck 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 Merck Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Merck Compound as set forth in this Section 8.7.2(b), (ii) indemnification under Section 13.2 (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 (Recalls). In the event that Merck Compound is lost or damaged after Delivery and as a result additional Merck Compound is necessary for the Study, Merck shall provide additional Merck Compound, if available for the Study, to Syndax, provided that *** shall *** for the *** of such additional Merck Compound, and provided further that Merck shall have no obligation to provide replacement Merck Compound for any Merck Compound supplied hereunder other than such Merck Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to Syndax. (c) Syndax shall be responsible for, and Merck shall have no obligations or liability with respect to, any Syndax Compound supplied hereunder that is found to have a Non-Conformance. Syndax shall replace any Syndax Compound as is found to have a Non-Conformance (with respect to Syndax 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 Merck with respect to any Syndax Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Syndax Compound as set forth in this Section 8.7.2(c), (ii) indemnification under Section 13.2 (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 Merck shall not be deemed to be waiving any rights under Section 8.15 (Recalls).
Appears in 2 contracts
Samples: Clinical Trial Collaboration and Supply Agreement (Syndax Pharmaceuticals Inc), Clinical Trial Collaboration and Supply Agreement (Syndax Pharmaceuticals Inc)
Non-Conformance. (a) 9.7.2.1 In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Sections 8.7.1 (After Manufacturer’s Release)), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8 (Resolution of Discrepancies).
(b) 9.7.2.2 In the event that any proposed or actual shipment of the Merck Pfizer Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to Syndax or shall otherwise be determined under the Clinical Quality Agreement to have a Non-Conformance at the time of Delivery to SyndaxIdeaya, then unless otherwise agreed to by the Parties, Merck Pfizer shall replace such Merck Pfizer Compound as is found to have a Non-Conformance (with respect to Merck Pfizer 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 Ideaya with respect to any Merck Pfizer Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Merck Pfizer Compound as set forth in this Section 8.7.2(b)8.7.2.2, (ii) indemnification under Section 13.2 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 Ideaya shall not be deemed to be waiving any rights under Section 8.15 (Recalls)8.15. In the event that Merck Pfizer Compound is lost or damaged after Delivery and as a result additional Merck Compound is necessary for the StudyDelivery, Merck shall Pfizer may provide additional Merck CompoundPfizer Compound to Ideaya, if available for the Study. Such replaced Pfizer Compound shall be provided at no cost to Ideaya, to Syndax, provided that so long as the amount replaced does not in the aggregate exceed [*** *] of the total quantity of Pfizer Compound to be provided by Pfizer pursuant to Appendix B (the “Replacement Threshold”). Ideaya shall *** for pay Pfizer the *** Manufacturing Costs of such additional Merck Compoundany replaced Pfizer Compound which Pfizer agrees to supply in excess of the Replacement Threshold. For the avoidance of doubt, and provided further that Merck Pfizer shall have no obligation to provide replacement Merck Pfizer Compound for any Merck Pfizer Compound supplied hereunder other than such Merck Pfizer Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to SyndaxIdeaya. Pfizer shall be responsible for any costs incurred by Ideaya [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. in connection with the return or destruction of any Pfizer Compound supplied hereunder that is found to have a Non-Conformance caused by Pfizer.
(c) Syndax 9.7.2.3 Ideaya shall be responsible for, and Merck Pfizer shall have no obligations or liability with respect to, any Syndax Ideaya Compound supplied hereunder that is found to have a Non-Conformance. Syndax Ideaya shall replace any Syndax Ideaya Compound as is found to have a Non-Conformance (with respect to Syndax Ideaya 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 Merck Pfizer with respect to any Syndax Ideaya Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Syndax Ideaya Compound as set forth in this Section 8.7.2(c)8.7.2.3, (ii) indemnification under Section 13.2 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 Merck Pfizer shall not be deemed to be waiving any rights under Section 8.15 (Recalls)8.15.
Appears in 2 contracts
Samples: Clinical Trial Collaboration and Supply Agreement (IDEAYA Biosciences, Inc.), Clinical Trial Collaboration and Supply Agreement (IDEAYA Biosciences, Inc.)
Non-Conformance. (a) In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Sections 8.7.1 (After Manufacturer’s Release)Section 8.8.1), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8 (Resolution of Discrepancies)8.8.3.
(b) In the event that any proposed or actual shipment of the Merck Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to Syndax or shall otherwise be determined under the Clinical Quality Agreement to have a Non-Conformance at the time of Delivery to SyndaxAdaptimmune, then unless otherwise agreed to by the Parties, Merck shall replace such Merck Compound as is found to have a Non-Conformance (with respect to Merck 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 Adaptimmune with respect to any Merck Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Merck Compound as set forth in this Section 8.7.2(b)*** , (ii) indemnification under Section 13.2 (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)*** ; providedprovided that, for clarity, that Syndax Adaptimmune shall not be deemed to be waiving any rights under Section 8.15 (Recalls)8.15. In the event that Merck Compound is lost or damaged by Adaptimmune after Delivery and as a result additional Merck Compound is necessary for the StudyDelivery, Merck shall provide additional Merck Compound, Compound (if available for the Study, ) to Syndax, Adaptimmune; provided that *** Adaptimmune shall *** for . Except as set forth in the *** of such additional Merck Compoundforegoing sentence, and provided further that Merck shall have no obligation to provide replacement Merck Compound for any Merck Compound supplied hereunder other than such Merck Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to SyndaxAdaptimmune.
(c) Syndax Adaptimmune shall be responsible for, and Merck shall have no obligations obligation or liability with respect to, any Syndax Adaptimmune Compound supplied hereunder that is found to have a Non-Conformance. Syndax Adaptimmune shall replace any Syndax Adaptimmune Compound as is found to have a Non-Conformance (with respect to Syndax Adaptimmune Compound that has not yet been administered or used in relation to any patient treatment in the course of performing the Study). Unless otherwise agreed to by the Parties in writing, the sole and exclusive remedies of Merck with respect to any Syndax Adaptimmune Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Syndax Compound as set forth in this Section 8.7.2(c)*** , (ii) indemnification under Section 13.2 *** (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*** ); providedprovided that, for clarity, that Merck shall not be deemed to be waiving any rights under Section 8.15 (Recalls)8.15.
Appears in 2 contracts
Samples: Clinical Trial Collaboration and Supply Agreement (Adaptimmune Therapeutics PLC), Clinical Trial Collaboration and Supply Agreement (Adaptimmune Therapeutics PLC)
Non-Conformance. (a) In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Sections 8.7.1 (After Manufacturer’s Release)), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality AgreementAgreements. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8 (Resolution of Discrepancies).
(b) In the event that any proposed or actual shipment of the Merck Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to Syndax Vaccinex or shall otherwise be determined under during the Clinical Quality Agreement to have shelf life set forth in Section 8.2 (in either case, a “Non-Conformance at the time of Delivery to SyndaxEvent”), then unless otherwise agreed to by the Parties, Merck shall replace such Merck Compound as is found to have a Non-Conformance (with respect to Merck 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 Vaccinex with respect to any Merck Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Merck Compound as set forth in this Section 8.7.2(b), (ii) indemnification under Section 13.2 14.2 (to the extent applicable) and (iii) termination of this Agreement pursuant to Section 6.3 or 6.7 (to the extent applicable, but subject to the applicable cure periods set forth therein); provided, for clarity, that Syndax Vaccinex shall not be deemed to be waiving any rights under Section 8.15 8.15.
(Recalls). c) In the event that Merck Compound is lost or damaged after Delivery and as a result Delivery, Merck may provide additional Merck Compound is necessary for the Study, Merck shall provide additional Merck Compoundto Vaccinex, if available for the Study. Such replaced Merck Compound shall be provided to Vaccinex, so long as the amount replaced does not in the aggregate exceed [***] of the total quantity of Merck Compound to Syndaxbe provided by Merck pursuant to Appendix B (such amount set forth on Appendix B, the “Replacement Note: Reference to “Merck” in this document refers to the Group of Companies affiliated with Merck KGaA, Darmstadt, Germany. Threshold”). Vaccinex shall pay Merck the Manufacturing Costs per vial of any replaced Merck Compound beyond the Replacement Threshold which Merck agrees to supply; provided that the Manufacturing Cost per vial of Merck Compound charged by Merck pursuant to this Section 8.7.2(b) shall not exceed US$[*** shall *** for ]. For the *** avoidance of such additional Merck Compounddoubt, and except as provided further that in this Section 8.7.2(c), Merck shall have no obligation to provide replacement Merck Compound for any Merck Compound supplied hereunder other than such Merck Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to SyndaxVaccinex.
(cd) Syndax Merck shall be responsible for any costs incurred by Vaccinex in connection with the return or destruction of any Merck Compound supplied hereunder that is found to have a Non-Conformance caused by Merck.
(e) Vaccinex shall be responsible for, and Merck shall have no obligations or liability with respect to, any Syndax Vaccinex Compound supplied hereunder that is found to have a Non-Conformance. Syndax Vaccinex shall replace any Syndax Vaccinex Compound as is found to have a Non-Conformance (with respect to Syndax Vaccinex 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 Merck with respect to any Syndax Vaccinex Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Syndax Vaccinex Compound as set forth in this Section 8.7.2(c), (ii) indemnification under Section 13.2 14.2 (to the extent applicable) and (iii) termination of this Agreement pursuant to Section 6.3 or 6.7 (to the extent applicable, but subject to the applicable cure periods set forth therein); provided, for clarity, that Merck shall not be deemed to be waiving any rights under Section 8.15 (Recalls)8.15.
Appears in 2 contracts
Samples: Clinical Trial Collaboration and Supply Agreement (Vaccinex, Inc.), Clinical Trial Collaboration and Supply Agreement (Vaccinex, Inc.)
Non-Conformance. (a) In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Sections 8.7.1 (After Manufacturer’s Release)Section 8.8.1), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8 (Resolution of Discrepancies)8.8.3.
(b) In the event that any proposed or actual shipment of the Merck Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to Syndax or shall otherwise be determined under the Clinical Quality Agreement to have a Non-Conformance at the time of Delivery to SyndaxFLX, then unless otherwise agreed to by the Parties, Merck shall replace such Merck Compound as is found to have a Non-Conformance (with respect to Merck 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 Merck Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Merck Compound as set forth in this Section 8.7.2(b), (ii) indemnification under Section 13.2 (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)[***]; providedprovided that, for clarity, that Syndax shall not be deemed to be waiving any rights under Section 8.15 (Recalls)[***]. In the event that Merck Compound is lost or damaged after Delivery and as a result additional Merck Compound is necessary for the Study[***], Merck shall provide additional Merck Compound, Compound (if available for the Study, ) to Syndax, FLX; provided that [*** shall *** for the *** of ] such additional replaced Merck Compound, ; and provided further that [***]. Except as set forth in the foregoing sentence, Merck shall have no obligation to provide replacement Merck Compound for any Merck Compound supplied hereunder other than such Merck Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to SyndaxFLX.
(c) Syndax FLX shall be responsible for, and Merck shall have no obligations obligation or liability with respect to, any Syndax FLX Compound supplied hereunder that is found to have a Non-Conformance. Syndax FLX shall replace any Syndax FLX Compound as is found to have a Non-Conformance (with respect to Syndax FLX 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 Merck [***] with respect to any Syndax FLX Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Syndax Compound as set forth in this Section 8.7.2(c), (ii) indemnification under Section 13.2 (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)[***]; providedprovided that, for clarity, that Merck shall not be deemed to be waiving any rights under Section 8.15 (Recalls)[***].
Appears in 2 contracts
Samples: Clinical Trial Collaboration and Supply Agreement (RAPT Therapeutics, Inc.), Clinical Trial Collaboration and Supply Agreement (RAPT Therapeutics, Inc.)
Non-Conformance. (a) In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Sections 8.7.1 (After Manufacturer’s Release)Section 8.8.1), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8 (Resolution of Discrepancies)8.8.3.
(b) In the event that any proposed or actual shipment of the Merck Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to Syndax or shall otherwise be determined under the Clinical Quality Agreement to have a Non-Conformance at the time of Delivery to SyndaxAntigen Express, then unless otherwise agreed to by the Parties, Merck shall replace such Merck Compound as is found to have a Non-Conformance (with respect to Merck 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 Antigen Express with respect to any Merck Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Merck Compound as set forth in this Section 8.7.2(b8.8.2(b), (ii) indemnification under Section 13.2 14.2.2 (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); providedprovided that, for clarity, that Syndax Antigen Express shall not be deemed to be waiving any rights under Section 8.15 (Recalls)8.15. In the event that Merck Compound is lost or damaged by Antigen Express after Delivery and as a result additional Merck Compound is necessary for the StudyDelivery, Merck shall provide additional Merck Compound, Compound (if available for the Study, ) to Syndax, Antigen Express; provided that *** Antigen Express shall *** reimburse Merck for the *** Direct Manufacturing Costs and Indirect Manufacturing Costs (as such terms are defined in Section 6.11) of such additional replaced Merck Compound, ; and provided further that Merck shall have no obligation to provide additional Merck Compound more than once. Except as set forth in the foregoing sentence, Merck shall have no obligation to provide replacement Merck Compound for any Merck Compound supplied hereunder other than such Merck Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to SyndaxAntigen Express.
(c) Syndax Antigen Express shall be responsible for, and Merck shall have no obligations obligation or liability with respect to, any Syndax Antigen Express Compound supplied hereunder that is found to have a Non-Conformance. Syndax Antigen Express shall replace any Syndax Antigen Express Compound as is found to have a Non-Conformance (with respect to Syndax Antigen Express 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 Merck with respect to any Syndax Antigen Express Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Syndax Antigen Express Compound as set forth in this Section 8.7.2(c8.8.2(c), (ii) indemnification under Section 13.2 (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 Merck shall not be deemed to be waiving any rights under Section 8.15 (Recalls).,
Appears in 2 contracts
Samples: Clinical Trial Collaboration and Supply Agreement (Nugenerex Immuno-Oncology, Inc.), Clinical Trial Collaboration and Supply Agreement (Generex Biotechnology Corp)
Non-Conformance. (a) a. In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Sections 8.7.1 (After Manufacturer’s 's Release)), such Party shall immediately notify the other Party in accordance with the procedures upon identification of the Clinical Quality AgreementNon-Conformance. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8 (Resolution of Discrepancies).
(b) b. In the event that any proposed or actual shipment of the Merck Menarini Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to Syndax or shall otherwise be determined under the Clinical Quality Agreement to have a Non-Conformance at the time of Delivery to SyndaxContext, then unless otherwise agreed to by the Parties, Merck Menarini shall promptly replace such Merck Menarini Compound as is found to have a Non-Conformance (with respect to Merck 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 Syndax Context with respect to any Merck Menarini Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) prompt replacement of such Merck Menarini Compound as set forth in this Section 8.7.2(b), and (ii) indemnification under Section 13.2 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 Context shall not be deemed to be waiving any rights under Section 8.15 (Recalls)8.15. In the event that Merck Menarini Compound is lost or damaged after Delivery and as Delivery, the Parties shall discuss a result additional Merck Compound is necessary for replacement supply at reasonable cost (which shall not exceed Menarini’s direct cost of goods of the Study, Merck shall provide additional Merck Menarini Compound, if available for the Study, to Syndax, provided that including shipment costs plus [*** shall *** for ]) and reasonable timelines. For the *** avoidance of such additional Merck Compounddoubt, and provided further that Merck Menarini shall have no obligation to provide replacement Merck Menarini Compound for any Merck Menarini Compound supplied hereunder other than such Merck Menarini Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to SyndaxContext. 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) Syndax c. Context shall be responsible for, and Merck Menarini shall have no obligations or liability with respect to, any Syndax Context Compound supplied hereunder that is found to have a Non-Conformance. Syndax Context shall replace any Syndax Context Compound as is found to have a Non-Conformance (with respect to Syndax 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 exclusive remedies of Merck Menarini with respect to any Syndax Context Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Syndax Context Compound as set forth in this Section 8.7.2(c), and (ii) indemnification under Section 13.2 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 Merck Menarini shall not be deemed to be waiving any rights under Section 8.15 (Recalls)8.15.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (Context Therapeutics Inc.)
Non-Conformance. (a) In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Sections 8.7.1 (After Manufacturer’s Release)Section 8.8.1), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8 (Resolution of Discrepancies)8.8.3.
(b) In the event that any proposed or actual shipment of the Merck Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to Syndax or shall otherwise be determined under the Clinical Quality Agreement to have a Non-Conformance at the time of Delivery to SyndaxCompany, then unless otherwise agreed to by the Parties, Merck shall replace such Merck Compound as is found to have a Non-Conformance (with respect to Merck 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 Company with respect to any Merck Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Merck Compound as set forth in this Section 8.7.2(b)[*****], (ii) indemnification under Section 13.2 (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)[*****]; providedprovided that, for clarity, that Syndax Company shall not be deemed to be waiving any rights under Section 8.15 (Recalls)8.15. In the event that Merck Compound is lost or damaged by Company after Delivery and as a result additional Merck Compound is necessary for the StudyDelivery, Merck shall provide additional Merck Compound, Compound (if available for the Study, ) to Syndax, Company; provided that Company shall [*** shall *** for *]. Except as set forth in the *** of such additional Merck Compoundforegoing sentence, and provided further that Merck shall have no obligation to provide replacement Merck Compound for any Merck Compound supplied hereunder other than such Merck Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to SyndaxCompany.
(c) Syndax Company shall be responsible for, and Merck shall have no obligations obligation or liability with respect to, any Syndax Company Compound supplied hereunder that is found to have a Non-Conformance. Syndax Company shall replace any Syndax Company Compound as is found to have a Non-Conformance (with respect to Syndax 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 exclusive remedies of Merck with respect to any Syndax Company Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Syndax Compound as set forth in this Section 8.7.2(c)[*****], (ii) indemnification under Section 13.2 (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)[*****]; providedprovided that, for clarity, that Merck shall not be deemed to be waiving any rights under Section 8.15 (Recalls)8.15.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (ONCOSEC MEDICAL Inc)
Non-Conformance. (a) In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Sections 8.7.1 (After Manufacturer’s Release)Section 8.8.1), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8 (Resolution of Discrepancies)8.8.3.
(b) In the event that any proposed or actual shipment of the Merck Compound (or portion thereof) shall be agreed or determined to have a Non-Conformance at the time of Delivery to Syndax or shall otherwise be determined under the Clinical Quality Agreement to have a Non-Conformance at the time of Delivery to SyndaxRexahn, then unless otherwise agreed to by the Parties, Merck shall replace such Merck Compound as is found to have a Non-Conformance (with respect to Merck 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 Rexahn with respect to any Merck Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Merck Compound as set forth in this Section 8.7.2(b), (ii) indemnification under Section 13.2 (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[***] provided that, for clarity, that Syndax Rexahn shall not be deemed to be waiving any rights under Section 8.15 (Recalls)8.15. In the event that Merck Compound is lost or damaged by Rexahn after Delivery and as a result additional Merck Compound is necessary for the StudyDelivery, Merck shall provide additional Merck Compound, Compound (if available for the Study, ) to Syndax, Rexahn; provided that Rexahn shall [*** shall *** for the *** ] of such additional replaced Merck Compound, ; and provided further that Merck shall have no obligation to [***]. Except as set forth in the foregoing sentence, Merck shall have no obligation to provide replacement Merck Compound for any Merck Compound supplied hereunder other than such Merck Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to SyndaxRexahn.
(c) Syndax Rexahn shall be responsible for, and Merck shall have no obligations obligation or liability with respect to, any Syndax Rexahn Compound supplied hereunder that is found to have a Non-Conformance. Syndax Rexahn shall replace any Syndax Rexahn Compound as is found to have a Non-Conformance (with respect to Syndax Rexahn 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 Merck with respect to any Syndax Rexahn Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Syndax Compound as set forth in this Section 8.7.2(c)[***], (ii) indemnification under Section 13.2 (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[***] provided that, for clarity, that Merck shall not be deemed to be waiving any rights under Section 8.15 (Recalls)8.15.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (Rexahn Pharmaceuticals, Inc.)
Non-Conformance. (a) In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Sections 8.7.1 (After Manufacturer’s Release)Section 8.8.1), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8 (Resolution of Discrepancies)8.8.3.
(b) In the event that any proposed or actual shipment of the Merck Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to Syndax or shall otherwise be determined under the Clinical Quality Agreement to have a Non-Conformance at the time of Delivery to SyndaxPDS, then unless otherwise agreed to by the Parties, Merck shall replace such Merck Compound as is found to have a Non-Conformance (with respect to Merck 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 PDS with respect to any Merck Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Merck Compound as set forth in this Section 8.7.2(b), 8.8.2(b) (ii) indemnification under Section 13.2 14.2.2 (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); providedprovided that, for clarity, that Syndax PDS shall not be deemed to be waiving any rights under Section 8.15 (Recalls)8.15. In the event that Merck Compound is lost or damaged by PDS after Delivery and as a result additional Merck Compound is necessary for the StudyDelivery, Merck shall provide additional Merck Compound, Compound (if available for the Study, ) to Syndax, PDS; provided that *** PDS shall *** reimburse Merck for the *** Direct Manufacturing Costs and Indirect Manufacturing Costs (as such terms are defined in Section 6.11) of such additional replaced Merck Compound, ; and provided further that Merck shall have no obligation to provide additional Merck Compound ***. Except as set forth in the foregoing sentence, Merck shall have no obligation to provide replacement Merck Compound for any Merck Compound supplied hereunder other than such Merck Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to SyndaxPDS.
(c) Syndax PDS shall be responsible for, and Merck shall have no obligations obligation or liability with respect to, any Syndax PDS Compound supplied hereunder that is found to have a Non-Conformance. Syndax PDS shall replace any Syndax PDS Compound as is found to have a Non-Conformance (with respect to Syndax PDS 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 Merck with respect to any Syndax PDS Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Syndax PDS Compound as set forth in this Section 8.7.2(c8.8.2(b), (ii) indemnification under Section 13.2 14.2.1 (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); providedprovided that, for clarity, that Merck shall not be deemed to be waiving any rights under Section 8.15 (Recalls)8.15. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filled separately with the Commission.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (Edge Therapeutics, Inc.)
Non-Conformance. (a) In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Sections 8.7.1 (After Manufacturer’s Release)), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality AgreementAgreements. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8 (Resolution of Discrepancies).
(b) In the event that any proposed or actual shipment of the Merck Alliance Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to Syndax Vaximm or shall otherwise be determined under during the Clinical Quality Agreement to have shelf life set forth in Section 8.2 (in either case, a Non-“Non- Conformance at the time of Delivery to SyndaxEvent”), then unless otherwise agreed to by the Parties, Merck the Alliance shall replace such Merck Compound have the obligations as is found to have a Non-Conformance (with respect to Merck Compound that has not yet been administered set forth in the course of performing the Studythis Section 8.7.2(b). Unless otherwise agreed to by the Parties in writing, the sole and exclusive remedies of Syndax Vaximm with respect to any Merck Alliance Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Merck Alliance Compound as set forth is found to have a Non-Conformance (with respect to Alliance Compound that has not yet been administered in this Section 8.7.2(bthe course of performing the Study), (ii) indemnification under Section 13.2 14.2 (to the extent applicable) and (iii) termination of this Agreement pursuant to Section 6.3 6 (to the extent applicable, but subject to the applicable cure periods set forth therein); provided, for clarity, that Syndax Vaximm shall not be deemed to be waiving any rights under Section 8.15 (Recalls)8.15. In the event that Merck Alliance Compound is lost or damaged after Delivery and as a result additional Merck Compound is necessary for Delivery, the Study, Merck shall Alliance may provide additional Merck CompoundAlliance Compound to Vaximm, if available for the Study; such replaced Alliance Compound shall be provided to Vaximm, so long as the amount replaced does not in the aggregate exceed five percent (5%) of the total quantity of Alliance Compound to Syndax, be provided by the Alliance pursuant to Appendix B (the “Replacement Threshold”); Vaximm shall pay the Alliance the Manufacturing Costs per vial of any replaced Alliance Compound which the Alliance agrees to supply; provided that *** the Manufacturing Costs per vial of Alliance Compound charged by the Alliance pursuant to this Section 8.7.2(b) shall *** for not exceed US$95.00. For the *** avoidance of such additional Merck Compounddoubt, and provided further that Merck the Alliance shall have no obligation to provide replacement Merck Alliance Compound for any Merck Alliance Compound supplied hereunder other than such Merck Alliance Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to Syndax.
(c) Syndax Vaximm. The Alliance shall be responsible for, and Merck shall have no obligations for any costs incurred by Vaximm in connection with the return or liability with respect to, destruction of any Syndax Alliance Compound supplied hereunder that is found to have a Non-ConformanceConformance caused by The Alliance. Syndax shall replace any Syndax Compound as is found to have a Non-Conformance (with respect to Syndax 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 Merck with respect to any Syndax Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Syndax Compound as set forth in this Section 8.7.2(c), (ii) indemnification under Section 13.2 (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 Merck shall not be deemed to be waiving any rights under Section 8.15 (Recalls).Upon thirty
Appears in 1 contract
Non-Conformance. (a) In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Sections 8.7.1 (After Manufacturer’s Release)Section 8.8.1), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8 (Resolution of Discrepancies)8.8.3.
(b) In the event that any proposed or actual shipment of the Merck MSD Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to Syndax or shall otherwise be determined under the Clinical Quality Agreement to have a Non-Conformance at the time of Delivery to SyndaxIntensity, then unless otherwise agreed to by the Parties, Merck MSD shall replace such Merck MSD Compound as is found to have a Non-Conformance (with respect to Merck 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 Syndax [***] with respect to any Merck MSD Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Merck Compound as set forth in this Section 8.7.2(b), (ii) indemnification under Section 13.2 (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[***] provided that, for clarity, that Syndax shall not be deemed to be waiving any rights under Section 8.15 (Recalls). [***] In the event that Merck MSD Compound is lost or damaged by Intensity after Delivery and as a result additional Merck Compound is necessary for the StudyDelivery, Merck MSD shall provide additional Merck Compound, if available for the Study, to Syndax, [***] provided that [*** shall *** for the *** of such additional Merck Compound, ] and provided further that Merck shall have no obligation to provide replacement Merck Compound for any Merck Compound supplied hereunder other than such Merck Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to Syndax[***].
(c) Syndax Intensity shall be responsible for, and Merck MSD shall have no obligations obligation or liability with respect to, any Syndax Intensity Compound supplied hereunder that is found to have a Non-Conformance. Syndax Intensity shall replace any Syndax Intensity Compound as is found to have a Non-Conformance (with respect to Syndax Intensity 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 Merck [***]with respect to any Syndax Intensity Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Syndax Compound as set forth in this Section 8.7.2(c), (ii) indemnification under Section 13.2 (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)be[***]; providedprovided that, for clarity, that Merck shall not be deemed to be waiving any rights under Section 8.15 (Recalls)[***] .
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (Intensity Therapeutics, Inc.)
Non-Conformance. (a) In the event that either Party becomes aware that any Compound may have a Non-Non- Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Sections 8.7.1 (After Manufacturer’s Release)Section 8.7.1), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any such Non-Conformance in accordance with Section 8.9 8.8 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8 (Resolution of Discrepancies)8.7.3.
(b) In the event that any proposed or actual shipment of the Merck ImmunoGen Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to Syndax or shall otherwise be determined under the Clinical Quality Agreement to have a Non-Conformance at the time of Delivery to SyndaxXxxxxxxx, then unless otherwise agreed to by the Parties, Merck ImmunoGen shall replace such Merck ImmunoGen Compound as is found to have a Non-Conformance (with respect to Merck ImmunoGen Compound that has not yet been administered in the course of performing the Study)) as soon as reasonably possible. Unless otherwise agreed to by the Parties in writing, the sole and exclusive remedies of Syndax Xxxxxxxx with respect to any Merck ImmunoGen Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Merck ImmunoGen Compound as set forth in this Section 8.7.2(b8.7.2b), (ii) indemnification under Section 13.2 13.2.2 (to the extent applicable) and (iii) termination of this Agreement pursuant to Section 6.6 or 6.3 (to the extent applicable, but subject to the applicable cure periods period set forth therein); provided, for clarity, that Syndax shall not be deemed to be waiving any rights under Section 8.15 (Recalls). In the event that Merck ImmunoGen Compound is lost or damaged by Xxxxxxxx after Delivery and as a result additional Merck Compound is necessary for the StudyDelivery, Merck ImmunoGen shall provide additional Merck Compound, ImmunoGen Compound (if available for the Study, ) to Syndax, Xxxxxxxx; provided that *** Xxxxxxxx shall *** reimburse ImmunoGen for the *** actual internal and out-of pocket costs reasonably incurred for such additional Merck replaced ImmunoGen Compound, ; and provided further that Merck ImmunoGen shall have no obligation to so provide additional ImmunoGen Compound more than once. Except as set forth in the foregoing sentence, ImmunoGen shall have no obligation to provide replacement Merck ImmunoGen Compound for any Merck ImmunoGen Compound supplied hereunder other than such Merck ImmunoGen Compound as has been agreed or determined to have a Non-Non- Conformance at the time of Delivery to SyndaxXxxxxxxx.
(c) Syndax Xxxxxxxx shall be responsible for, and Merck ImmunoGen shall have no obligations or liability with respect to, any Syndax Xxxxxxxx Compound supplied hereunder that is found to have a Non-Non- Conformance. Syndax shall replace any Syndax Compound as is found to have a Non-Conformance (with respect to Syndax 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 Merck with respect to any Syndax Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Syndax Compound as set forth in this Section 8.7.2(c), (ii) indemnification under Section 13.2 (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 Merck shall not be deemed to be waiving any rights under Section 8.15 (Recalls).
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (Shattuck Labs, Inc.)
Non-Conformance. (a) In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Sections 8.7.1 (After Manufacturer’s Release)Section 8.8.1), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8 (Resolution of Discrepancies)8.8.3.
(b) In the event that any proposed or actual shipment of the Merck Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to Syndax or shall otherwise be determined under the Clinical Quality Agreement to have a Non-Conformance at the time of Delivery to SyndaxCompany, then unless otherwise agreed to by the Parties, Merck shall replace such Merck Compound as is found to have a Non-Conformance (with respect to Merck 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 Company with respect to any Merck Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Merck Compound as set forth in this Section 8.7.2(b)*, (ii) indemnification under Section 13.2 (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)*; providedprovided that, for clarity, that Syndax Company shall not be deemed to be waiving any rights under Section 8.15 (Recalls)8.15. In the event that Merck Compound is lost or damaged by Company after Delivery and as a result additional Merck Compound is necessary for the StudyDelivery, Merck shall provide additional Merck Compound, Compound (if available for the Study, ) to Syndax, Company; provided that *** Company shall *** for . Except as set forth in the *** of such additional Merck Compoundforegoing sentence, and provided further that Merck shall have no obligation to provide replacement Merck Compound for any Merck Compound supplied hereunder other than such Merck Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to SyndaxCompany.
(c) Syndax Company shall be responsible for, and Merck shall have no obligations obligation or liability with respect to, any Syndax Company Compound supplied hereunder that is found to have a Non-Conformance. Syndax Company shall replace any Syndax Company Compound as is found to have a Non-Conformance (with respect to Syndax 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 exclusive remedies of Merck with respect to any Syndax Company Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Syndax Compound as set forth in this Section 8.7.2(c)*, (ii) indemnification under Section 13.2 (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)*; providedprovided that, for clarity, that Merck shall not be deemed to be waiving any rights under Section 8.15 (Recalls)8.15. *Confidential material redacted and filed separately with the Commission.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (ONCOSEC MEDICAL Inc)
Non-Conformance. (a) In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Sections 8.7.1 (After Manufacturer’s Release)Section 8.8.1), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8 (Resolution of Discrepancies)8.8.3.
(b) In the event that any proposed or actual shipment of the Merck MSD Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to Syndax or shall otherwise be determined under the Clinical Quality Agreement to have a Non-Conformance at the time of Delivery to SyndaxCompany, then unless otherwise agreed to by the Parties, Merck shall MSD shall, at its own expense, replace such Merck MSD Compound as is found to have a Non-Conformance (with respect to Merck 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 Syndax Company with respect to any Merck MSD Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Merck Compound as set forth in this Section 8.7.2(b), (ii) indemnification under Section 13.2 (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 (Recalls)[***]. In the event that Merck MSD Compound is lost or damaged by Company after Delivery and as a result additional Merck Compound is necessary for the StudyDelivery, Merck MSD shall provide additional Merck Compound, if available for the Study, to Syndax, provided that [*** shall *]; provided, that, [*** for *]. Except as set forth in the foregoing sentence, MSD shall have [*** of such additional Merck Compound, and provided further that Merck shall have no obligation to provide replacement Merck Compound *] for any Merck MSD Compound supplied hereunder other than such Merck MSD Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to SyndaxCompany.
(c) Syndax Company shall be responsible for, and Merck MSD shall have no obligations obligation or liability with respect to, any Syndax Company Compound supplied hereunder that is found to have a Non-Conformance. Syndax shall Company shall, at its own expense, replace any Syndax Company Compound as is found to have a Non-Conformance (with respect to Syndax 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 exclusive remedies of Merck MSD with respect to any Syndax Company Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Syndax Compound as set forth in this Section 8.7.2(c), (ii) indemnification under Section 13.2 (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[***] provided that, for clarity, that Merck MSD shall not be deemed to be waiving any rights under Section 8.15 (Recalls)8.15.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (IMMUTEP LTD)
Non-Conformance. (a) In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Sections 8.7.1 (After Manufacturer’s Release)Section 8.8.1), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8 (Resolution of Discrepancies)8.8.3.
(b) In the event that any proposed or actual shipment of the Merck Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to Syndax or shall otherwise be determined under the Clinical Quality Agreement to have a Non-Conformance at the time of Delivery to SyndaxCompany, then unless otherwise agreed to by the Parties, Merck shall replace such Merck Compound as is found to have a Non-Conformance (with respect to Merck 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 Company with respect to any Merck Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Merck Compound as set forth in this Section 8.7.2(b)[*****], (ii) indemnification under Section 13.2 (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)[*****]; providedprovided that, for clarity, that Syndax Company shall not be deemed to be waiving any rights under Section 8.15 (Recalls)8.15. In the event that Merck Compound is lost or damaged by Company after Delivery and as a result additional Merck Compound is necessary for the StudyDelivery, Merck shall provide additional Merck Compound, Compound (if available for the Study, ) to Syndax, Company; provided that Company shall [*** shall *** for *]. Except as set forth in the *** of such additional Merck Compoundforegoing sentence, and provided further that Merck shall have no obligation to provide replacement Merck Compound for any Merck Compound supplied hereunder other than such Merck Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to SyndaxCompany.
(c) Syndax Company shall be responsible for, and Merck shall have no obligations obligation or liability with respect to, any Syndax Company Compound supplied hereunder that is found to have a Non-Conformance. Syndax Company shall replace any Syndax Company Compound as is found to have a Non-Conformance (with respect to Syndax 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 exclusive remedies of Merck with respect to any Syndax Company Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Syndax Compound as set forth in this Section 8.7.2(c)[*****], (ii) indemnification under Section 13.2 (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); providedprovided that, for clarity, that Merck shall not be deemed to be waiving any rights under Section 8.15 (Recalls)8.15.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (ONCOSEC MEDICAL Inc)
Non-Conformance. (a) In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Sections 8.7.1 (After Manufacturer’s Release)), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8 (Resolution of Discrepancies). Certain portions of this document have been marked “[C.I.]” to indicate that confidential treatment has been requested for such confidential information. The confidential portions have been omitted and submitted separately with the Securities and Exchange Commission.
(b) In the event that any proposed or actual shipment of the Merck Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to Syndax or shall otherwise be determined under the Clinical Quality Agreement to have a Non-Conformance at the time of Delivery to SyndaxAdvaxis, then unless otherwise agreed to by the Parties, Merck shall replace such Merck Compound as is found to have a Non-Conformance (with respect to Merck 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 Advaxis with respect to any Merck Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Merck Compound as set forth in this Section 8.7.2(b), (ii) indemnification under Section 13.2 14.2 (to the extent applicable) and (iii) termination of this Agreement pursuant to Section 6.3 6.4 (to the extent applicable, but subject to the applicable cure periods set forth therein); providedprovided that, for clarity, that Syndax Advaxis shall not be deemed to be waiving any rights under Section 8.15 (Recalls)8.16. In the event that Merck Compound is lost or damaged by Advaxis after Delivery and as a result additional Merck Compound is necessary for the StudyDelivery, Merck shall provide additional Merck Compound, Compound (if available for the Study, ) to Syndax, Advaxis; provided that *** Advaxis shall *** reimburse Merck for the *** Direct Manufacturing Costs and Indirect Manufacturing Costs (as such terms are defined in Section 6.11) of such additional replaced Merck Compound, ; and provided further that Merck shall have no obligation to provide additional Merck Compound more than once. Except as set forth in the foregoing sentence, Merck shall have no obligation to provide replacement Merck Compound for any Merck Compound supplied hereunder other than such Merck Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to SyndaxAdvaxis.
(c) Syndax Advaxis shall be responsible for, and Merck shall have no obligations or liability with respect to, any Syndax Advaxis Compound supplied hereunder that is found to have a Non-Conformance. Syndax Advaxis shall replace any Syndax Advaxis Compound as is found to have a Non-Conformance (with respect to Syndax Advaxis 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 Merck with respect to any Syndax Advaxis Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Syndax Advaxis Compound as set forth in this Section 8.7.2(c), (ii) indemnification under Section 13.2 14.2 (to the extent applicable) and (iii) termination of this Agreement pursuant to Section 6.3 6.4 (to the extent applicable, but subject to the applicable cure periods set forth therein); providedprovided that, for clarity, that Merck shall not be deemed to be waiving any rights under Section 8.15 (Recalls)8.16.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (Advaxis, Inc.)
Non-Conformance. (a) In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Sections 8.7.1 (After Manufacturer’s Release)Section 8.8.1), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8 (Resolution of Discrepancies)8.8.3.
(b) In the event that any proposed or actual shipment of the Merck Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to Syndax or shall otherwise be determined under the Clinical Quality Agreement to have a Non-Conformance at the time of Delivery to SyndaxCompany, then unless otherwise agreed to by the Parties, Merck shall shall, at its own expense, replace such Merck Compound as is found to have a Non-Non- Conformance (with respect to Merck 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 Company with respect to any Merck Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Merck Compound as set forth in this Section 8.7.2(b), (ii) indemnification under Section 13.2 (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 (Recalls)****. In the event that Merck Compound is lost or damaged by Company after Delivery and as a result additional Merck Compound is necessary for the StudyDelivery, Merck shall provide additional Merck Compound, Compound (if available for the Study, ) to Syndax, Company; provided that *** shall *** for . Except as set forth in the *** of such additional Merck Compoundforegoing sentence, and provided further that Merck shall have no obligation to provide replacement Merck Compound for any Merck Compound supplied hereunder other than such Merck Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to SyndaxCompany.
(c) Syndax Company shall be responsible for, and Merck shall have no obligations obligation or liability with respect to, any Syndax Company Compound supplied hereunder that is found to have a Non-Conformance. Syndax shall Company shall, at its own expense, replace any Syndax Company Compound as is found to have a Non-Conformance (with respect to Syndax 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 exclusive remedies of Merck with respect to any Syndax Company Compound that is found to have a Non-Non- Conformance at the time of Delivery shall be (i) replacement of such Syndax Compound as set forth in this Section 8.7.2(c), (ii) indemnification under Section 13.2 (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)****; providedprovided that, for clarity, that Merck shall not be deemed to be waiving any rights under Section 8.15 (Recalls)8.15.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (IMMUTEP LTD)
Non-Conformance. (a) 8.7.2.1. In the event that either Party Incyte becomes aware that any the Advaxis Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Sections 8.7.1 (After Manufacturer’s Release)), such Party Incyte shall immediately notify the other Party Advaxis in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8 (Resolution of Discrepancies).
(b) 8.7.2.2. In the event that any proposed or actual shipment of the Merck Advaxis Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to Syndax or shall otherwise be determined under the Clinical Quality Agreement to have a Non-Conformance at the time of Delivery to SyndaxIncyte, then unless otherwise agreed to by the Parties, Merck Advaxis shall replace such Merck the non-conforming Advaxis Compound as is found to have a Non-Conformance (with respect to Merck Advaxis 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 Incyte with respect to any Merck Advaxis Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Merck Advaxis Compound as set forth in this Section 8.7.2(b)8.7.2.2, (ii) indemnification under Section 13.2 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); providedprovided that, for clarity, that Syndax Incyte shall not be deemed to be waiving any rights under Section 8.15 (Recalls)8.16. In the event that Merck Advaxis Compound is lost or damaged by Incyte after Delivery and as a result additional Merck Compound is necessary for the StudyDelivery, Merck Advaxis shall provide additional Merck Compound, if available Advaxis Compound to Incyte; provided that Incyte shall reimburse Advaxis for the Studymanufacturing and shipping costs of the replaced Advaxis Compound. Except as set forth in the foregoing sentence, to Syndax, provided that *** shall *** for the *** of such additional Merck Compound, and provided further that Merck Advaxis shall have no obligation to provide replacement Merck Advaxis Compound for any Merck Advaxis Compound supplied hereunder other than such Merck Advaxis Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to SyndaxIncyte.
(c) Syndax 8.7.2.3. Incyte shall be responsible for, and Merck Advaxis shall have no obligations or liability with respect to, any Syndax Incyte Compound supplied hereunder that is found to have a Non-Conformance. Syndax Incyte shall replace any Syndax Incyte Compound as is found to have a Non-Conformance (with respect to Syndax Incyte 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 Merck Advaxis with respect to any Syndax Incyte Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Syndax Incyte Compound as set forth in this Section 8.7.2(c)8.7.2.3, (ii) indemnification under Section 13.2 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); providedprovided that, for clarity, that Merck Advaxis shall not be deemed to be waiving any rights under Section 8.15 (Recalls)8.16.
Appears in 1 contract
Samples: Clinical Study Collaboration Agreement (Advaxis, Inc.)
Non-Conformance. (a) i. In the event that either a Party becomes aware that any 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 (including any activities conducted by the Parties under Sections 8.7.1 (After Manufacturer’s Release))activities, then such Party shall immediately will notify the other Party Party’s relevant Quality contact set forth in accordance with the procedures Attachment C (or as updated) within [**] Business Days of becoming aware of the Clinical Quality AgreementNon-Conformance. The Parties shall Idera and AbbVie will investigate any Non-Conformance as set forth in accordance with Section 8.9 6(b)(ii) (Investigations) below and any discrepancy between them 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 resolved in accordance with Section 8.8 (Resolution 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 Discrepancies).
(b) Delivery of such Idera Compound. In the event that any proposed or actual shipment of the Merck Idera Compound (or portion thereof) shall will be agreed to have a Non-Conformance at the time of Delivery to Syndax or shall otherwise be determined under the Clinical Quality Agreement to have a Non-Conformance at the time of Delivery to Syndax, then unless otherwise agreed to by the Parties, Merck shall replace such Merck Compound as is found to have a Non-Conformance (with respect to Merck 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 Merck Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Merck Compound as set forth in this Section 8.7.2(b), (ii) indemnification under Section 13.2 (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 (Recalls). In the event that Merck Compound is lost or damaged after Delivery and as a result additional Merck Compound is necessary for the Study, Merck shall provide additional Merck Compound, if available for the Study, to Syndax, provided that *** shall *** for the *** of such additional Merck Compound, and provided further that Merck shall have no obligation to provide replacement Merck Compound for any Merck Compound supplied hereunder other than such Merck Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to Syndax.
(c) Syndax shall be responsible forAbbVie, and Merck shall have no obligations or liability with respect tothen unless otherwise agreed to by the Parties in writing, any Syndax Compound supplied hereunder that is found Idera will use commercially reasonable efforts to have a Non-Conformance. Syndax shall replace any Syndax such Idera Compound as is found to have a Non-Conformance (with respect as soon as reasonably practical and at no cost to Syndax AbbVie. Any Idera Compound that has not yet been administered in the course rejected by written notice to Idera within [**] days of performing the Study). Unless otherwise agreed to by the Parties in writingAbbVie’s receipt shall be deemed accepted, the sole and exclusive remedies of Merck with respect to any Syndax except for Idera Compound that is found later to have a Non-Conformance at the time had latent defect(s) that were not reasonably discoverable within [**] days after receipt of Delivery shall be (i) replacement of such Syndax Compound as set forth in this Section 8.7.2(c), (ii) indemnification under Section 13.2 (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 Merck shall not be deemed to be waiving any rights under Section 8.15 (Recalls)Idera Compound.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (Idera Pharmaceuticals, Inc.)
Non-Conformance. (a) In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Sections 8.7.1 (After Manufacturer’s Release)Section 8.5.1), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 8.7 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8 8.6 (Resolution of Discrepancies).
(b) In the event that any proposed or actual shipment of the Merck Lilly Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to Syndax or shall otherwise be determined under the Clinical Quality Agreement to have a Non-Conformance at the time of Delivery to SyndaxSponsor, then unless otherwise agreed to by the Parties, Merck Lilly shall replace such Merck Lilly Compound as is found to have a Non-Conformance (with respect to Merck the Lilly 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 Sponsor with respect to any Merck Lilly Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Merck Lilly Compound as set forth in this Section 8.7.2(b8.5.2(b), (ii) indemnification under Section 13.2 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 (Recalls). In the event that Merck Lilly Compound is lost or damaged after Delivery and as a result additional Merck Compound is necessary for the StudyDelivery, Merck Lilly shall provide additional Merck CompoundLilly Compound to Sponsor, if available for the Study, to Syndax, provided that *** Sponsor shall *** reimburse Lilly for the *** Direct Manufacturing Costs and Indirect Manufacturing Costs of such additional Merck Compoundreplaced Lilly Compound to the extent that the loss or damage is due to the negligence of Sponsor or any of its vendors, subcontractors or Affiliates, and provided further that Merck Lilly shall have no obligation to provide replacement Merck Lilly Compound for any Merck Lilly Compound supplied hereunder other than such Merck Lilly Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to SyndaxSponsor (so long as such Non-Conformance was discovered within a reasonable time period). "Direct Manufacturing Costs" shall be calculated consistent with Generally CONFIDENTIAL Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025 Page 17 [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not material and (II) would be competitively harmful if publicly disclosed.
(c) Syndax Sponsor shall be responsible for, and Merck Lilly shall have no obligations or liability with respect to, any Syndax Sponsor Compound supplied hereunder that is found to have a Non-Conformance. Syndax Sponsor shall replace any Syndax Sponsor Compound as is found to have a Non-Conformance (with respect to Syndax Sponsor 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 Merck Lilly with respect to any Syndax Sponsor Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Syndax Sponsor Compound as set forth in this Section 8.7.2(c8.5.2(c), (ii) indemnification under Section 13.2 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 Merck shall not be deemed to be waiving any rights under Section 8.15 (Recalls).
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (Pieris Pharmaceuticals, Inc.)
Non-Conformance. (a) In the event that either Party becomes aware that any Compound Compounds may have a Non-Conformance, despite any testing and quality assurance activities (including any activities conducted by the Parties under Sections 8.7.1 Section 12.7 (After Manufacturer’s Release)), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 12.10 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8 12.9 (Resolution of Discrepancies).
(b) In the event that any proposed or actual shipment of the Merck SpringWorks Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to Syndax or shall otherwise be determined under the Clinical Quality Agreement to have a Non-Conformance at the time of Delivery to SyndaxGSK, then unless otherwise agreed to by the Parties, Merck SpringWorks shall replace such Merck SpringWorks Compound as is found to have a Non-Conformance (with respect to Merck Compound that has not yet been administered in the course of performing the Study)Conformance. Unless otherwise agreed to by the Parties in writing, the sole and exclusive remedies of Syndax GSK with respect to any Merck SpringWorks Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Merck SpringWorks Compound as set forth in this Section 8.7.2(b12.8(b), and (ii) indemnification under Section 13.2 Article 22 (to the extent applicable) and (iii) termination of this Agreement pursuant to Section 6.3 24.2 (to the extent applicable, but subject to the applicable cure periods set forth therein); provided, provided that, for clarity, that Syndax GSK shall not be deemed to be waiving any of its rights under Section 8.15 (Recalls)to recall Compounds in accordance with the Clinical Quality Agreement. In the event that Merck SpringWorks Compound is lost or damaged by GSK after Delivery and as a result additional Merck Compound is necessary for the StudyDelivery, Merck SpringWorks shall provide additional Merck Compound, SpringWorks Compound (if available for the Sub-Study, ) to Syndax, GSK; provided that *** GSK shall *** reimburse SpringWorks for the *** actual cost of such additional Merck Compound, and provided further that Merck shall have no obligation to provide replacement Merck replaced SpringWorks Compound for any Merck Compound supplied hereunder other than such Merck Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to Syndaxwithout markup.
(c) Syndax GSK shall be responsible for, and Merck SpringWorks shall have no obligations or liability with respect to, any Syndax GSK Compound supplied hereunder that is found to have a Non-Conformance. Syndax GSK shall replace any Syndax GSK Compound as is found to have a Non-Conformance (with respect to Syndax Compound that has not yet been administered in the course of performing the Study)Conformance. Unless otherwise agreed to by the Parties in writing, the sole and exclusive remedies of Merck SpringWorks with respect to any Syndax GSK Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Syndax GSK Compound as set forth in this Section 8.7.2(c), 12.8(c) and (ii) indemnification under Section 13.2 Article 22 (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 Merck shall not be deemed to be waiving any rights under Section 8.15 (Recalls).
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (SpringWorks Therapeutics, Inc.)
Non-Conformance. (a) In the event that either Party becomes aware that any Compound Compounds may have a Non-Non- Conformance, despite any testing and quality assurance activities (including any activities conducted by the Parties under Sections 8.7.1 Section 12.11 (After Manufacturer’s Release)), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 12.14 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8 12.13 (Resolution of Discrepancies).
(b) In the event that any proposed or actual shipment of the Merck SpringWorks Compound (or portion thereof) shall be is agreed to have a Non-Conformance at the time of Delivery to Syndax or shall otherwise be determined under the Clinical Quality Agreement to have a Non-Conformance at the time of Delivery to SyndaxGSK, then unless otherwise agreed to by the Parties, Merck SpringWorks shall replace such Merck SpringWorks Compound as is found to have a Non-Conformance (with respect to Merck Compound that has not yet been administered in the course of performing the Study)Conformance. Unless otherwise agreed to by the Parties in writing, the sole and exclusive remedies of Syndax GSK with respect to any Merck SpringWorks Compound that is found to have a Non-Non- Conformance at the time of Delivery shall be (i) replacement of such Merck SpringWorks Compound as set forth in this Section 8.7.2(b12.12(b), and (ii) indemnification under Section 13.2 Article 22 (to the extent applicable) and (iii) termination of this Agreement pursuant to Section 6.3 24.2 (to the extent applicable, but subject to the applicable cure periods set forth therein); provided, provided that, for clarity, that Syndax GSK shall not be deemed to be waiving any of its rights under Section 8.15 (Recalls)to recall Compounds in accordance with the Clinical Quality Agreement. In the event that Merck SpringWorks Compound is lost or damaged by GSK after Delivery and as a result additional Merck Compound is necessary for the StudyDelivery, Merck SpringWorks shall use Commercially Reasonable Efforts to provide additional Merck Compound, if available for the Study, SpringWorks Compound to Syndax, GSK; provided that *** shall *** for the *** of such additional Merck Compound, and provided further that Merck shall have no obligation to provide replacement Merck Compound for any Merck Compound supplied hereunder other than such Merck Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to Syndax.GSK shall
(c) Syndax GSK shall be responsible for, and Merck SpringWorks shall have no obligations or liability with respect to, any Syndax Compound supplied hereunder GSK BCMA Product that is found to have a Non-Non- Conformance. Syndax shall replace any Syndax Compound as is found to have a Non-Conformance (with respect to Syndax 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 Merck with respect to any Syndax Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Syndax Compound as set forth in this Section 8.7.2(c), (ii) indemnification under Section 13.2 (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 Merck shall not be deemed to be waiving any rights under Section 8.15 (Recalls).
Appears in 1 contract
Samples: Collaboration and License Agreement (SpringWorks Therapeutics, Inc.)
Non-Conformance. (a) In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Sections 8.7.1 (After Manufacturer’s Release)), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality AgreementAgreements. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8 (Resolution of Discrepancies).
(b) In the event that any proposed or actual shipment of the Merck Alliance Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to Syndax or shall otherwise be determined under during the Clinical Quality Agreement to have shelf life set forth in Section 8.2 (in either case, a “Non-Conformance at the time of Delivery to SyndaxEvent”), then unless otherwise agreed to by the Parties, Merck the Alliance shall replace such Merck Alliance Compound as is found to have a Non-Conformance (with respect to Merck 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 Merck Alliance Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Merck Alliance Compound as set forth in this Section 8.7.2(b), (ii) indemnification under Section 13.2 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 (Recalls)8.15. In the event that Merck Alliance Compound is lost or damaged after Delivery and as a result additional Merck Compound is necessary for Delivery, the Study, Merck shall Alliance may provide additional Merck CompoundAlliance Compound to Syndax, if available for the Study. Such replaced Alliance Compound shall ***, to Syndax, provided that 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 *. For the *** avoidance of such additional Merck Compounddoubt, and provided further that Merck the Alliance shall have no obligation to provide replacement Merck Alliance Compound for any Merck Alliance Compound supplied hereunder other than such Merck Alliance Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to Syndax.
(c) Syndax . The Alliance shall be responsible for, and Merck shall have no obligations for any costs incurred by Syndax in connection with the return or liability with respect to, destruction of any Syndax Alliance Compound supplied hereunder that is found to have a Non-Conformance. Syndax shall replace any Syndax Compound as is found to have a Non-Conformance (with respect to Syndax 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 Merck with respect to any Syndax Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Syndax Compound as set forth in this Section 8.7.2(c), (ii) indemnification under Section 13.2 (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 Merck shall not be deemed to be waiving any rights under Section 8.15 (Recalls).supplied
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (Syndax Pharmaceuticals Inc)