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 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 8.8.3. (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 Adaptimmune, 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 Adaptimmune with respect to any Merck Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) *** , (ii) *** , and (iii) *** ; provided that, for clarity, Adaptimmune shall not be deemed to be waiving any rights under Section 8.15. In the event Merck Compound is lost or damaged by Adaptimmune after Delivery, Merck shall provide additional Merck Compound (if available for the Study) to Adaptimmune; provided that Adaptimmune shall *** . 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 Adaptimmune. (c) Adaptimmune shall be responsible for, and Merck shall have no obligation or liability with respect to, any Adaptimmune Compound supplied hereunder that is found to have a Non-Conformance. Adaptimmune shall replace any Adaptimmune Compound as is found to have a Non-Conformance (with respect to 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 Adaptimmune Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) *** , (ii) *** (to the extent applicable), and (iii) *** (to the extent applicable, *** ); provided that, for clarity, Merck shall not be deemed to be waiving any rights under Section 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 Section 8.8.1Sections 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 8.8.38.8 (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 AdaptimmuneSyndax 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 Adaptimmune 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 thatprovided, for clarity, Adaptimmune that Syndax shall not be deemed to be waiving any rights under Section 8.158.15 (Recalls). In the event that Merck Compound is lost or damaged by Adaptimmune after DeliveryDelivery 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 Adaptimmune; Syndax, provided that Adaptimmune *** shall *** . Except as set forth in for the foregoing sentence*** 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 AdaptimmuneSyndax.
(c) Adaptimmune Syndax shall be responsible for, and Merck shall have no obligation obligations or liability with respect to, any Adaptimmune Syndax Compound supplied hereunder that is found to have a Non-Conformance. Adaptimmune Syndax shall replace any Adaptimmune Syndax Compound as is found to have a Non-Conformance (with respect to Adaptimmune Syndax 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 Adaptimmune 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 thatprovided, for clarity, that Merck shall not be deemed to be waiving any rights under Section 8.158.15 (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) 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 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 8.8.3.
(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 AdaptimmuneFLX, 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 Adaptimmune [***] with respect to any Merck Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) [*** , (ii) *** , and (iii) *** ]; provided that, for clarity, Adaptimmune shall not be deemed to be waiving any rights under Section 8.15[***]. In the event Merck Compound is lost or damaged by Adaptimmune after Delivery[***], Merck shall provide additional Merck Compound (if available for the Study) to AdaptimmuneFLX; provided that Adaptimmune shall [*** *] such 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 AdaptimmuneFLX.
(c) Adaptimmune FLX shall be responsible for, and Merck shall have no obligation or liability with respect to, any Adaptimmune FLX Compound supplied hereunder that is found to have a Non-Conformance. Adaptimmune FLX shall replace any Adaptimmune FLX Compound as is found to have a Non-Conformance (with respect to Adaptimmune FLX 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 Adaptimmune FLX Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) [*** , (ii) *** (to the extent applicable), and (iii) *** (to the extent applicable, *** )]; provided that, for clarity, Merck shall not be deemed to be waiving any rights under Section 8.15[***].
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 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 8.8.3.
(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 AdaptimmuneAntigen 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 Adaptimmune 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 8.8.2(b), (ii) *** indemnification under Section 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); provided that, for clarity, Adaptimmune Antigen Express shall not be deemed to be waiving any rights under Section 8.15. In the event Merck Compound is lost or damaged by Adaptimmune Antigen Express after Delivery, Merck shall provide additional Merck Compound (if available for the Study) to AdaptimmuneAntigen Express; provided that Adaptimmune 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 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 AdaptimmuneAntigen Express.
(c) Adaptimmune Antigen Express shall be responsible for, and Merck shall have no obligation or liability with respect to, any Adaptimmune Antigen Express Compound supplied hereunder that is found to have a Non-Conformance. Adaptimmune Antigen Express shall replace any Adaptimmune Antigen Express Compound as is found to have a Non-Conformance (with respect to Adaptimmune Antigen Express 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 Adaptimmune Antigen Express Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) *** , (ii) *** (to the extent applicablereplacement of such Antigen Express Compound as set forth in this Section 8.8.2(c), and (iii) *** (to the extent applicable, *** ); provided that, for clarity, Merck shall not be deemed to be waiving any rights under Section 8.15.,
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) 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 Section 8.8.1Sections 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 8.8.38.8 (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 AdaptimmuneVaccinex or during the shelf life set forth in Section 8.2 (in either case, a “Non-Conformance Event”), then unless otherwise agreed to by the Parties, 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 Adaptimmune 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 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 thatprovided, for clarity, Adaptimmune that Vaccinex shall not be deemed to be waiving any rights under Section 8.15. .
(c) In the event that Merck Compound is lost or damaged by Adaptimmune after Delivery, Merck shall may provide additional Merck Compound (to Vaccinex, if available for the Study) . Such replaced Merck Compound shall be provided to AdaptimmuneVaccinex, so long as the amount replaced does not in the aggregate exceed [***] of the total quantity of Merck Compound to be 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 Adaptimmune the Manufacturing Cost per vial of Merck Compound charged by Merck pursuant to this Section 8.7.2(b) shall not exceed US$[*** *]. Except For the avoidance of doubt, except as set forth provided in the foregoing sentencethis 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 AdaptimmuneVaccinex.
(cd) Adaptimmune 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 obligation obligations or liability with respect to, any Adaptimmune Vaccinex Compound supplied hereunder that is found to have a Non-Conformance. Adaptimmune Vaccinex shall replace any Adaptimmune Vaccinex Compound as is found to have a Non-Conformance (with respect to Adaptimmune Vaccinex 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 Adaptimmune Vaccinex Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) *** replacement of such Vaccinex Compound as set forth in this Section 8.7.2(c), (ii) *** indemnification under Section 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 thatprovided, for clarity, that Merck shall not be deemed to be waiving any rights under Section 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) 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 Section 8.8.1Sections 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 8.8.38.8 (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 AdaptimmuneIdeaya, 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 Adaptimmune 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 Pfizer Compound as set forth in this Section 8.7.2.2, (ii) *** , indemnification under Section 14.2 (to the extent applicable) and (iii) *** termination of this Agreement pursuant to Section 6.3 (to the extent applicable, but subject to the applicable cure periods set forth therein); provided thatprovided, for clarity, Adaptimmune that Ideaya shall not be deemed to be waiving any rights under Section 8.15. In the event Merck that Pfizer Compound is lost or damaged by Adaptimmune after Delivery, Merck shall Pfizer may provide additional Merck Pfizer Compound (to Ideaya, if available for the Study) . Such replaced Pfizer Compound shall be provided at no cost to Adaptimmune; provided that Adaptimmune shall Ideaya, 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”). Except as set forth Ideaya shall pay Pfizer the Manufacturing Costs of any replaced Pfizer Compound which Pfizer agrees to supply in excess of the foregoing sentenceReplacement Threshold. For the avoidance of doubt, 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 AdaptimmuneIdeaya. 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) Adaptimmune 9.7.2.3 Ideaya shall be responsible for, and Merck Pfizer shall have no obligation obligations or liability with respect to, any Adaptimmune Ideaya Compound supplied hereunder that is found to have a Non-Conformance. Adaptimmune Ideaya shall replace any Adaptimmune Ideaya Compound as is found to have a Non-Conformance (with respect to Adaptimmune Ideaya 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 Pfizer with respect to any Adaptimmune Ideaya Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) *** replacement of such Ideaya Compound as set forth in this Section 8.7.2.3, (ii) *** indemnification under Section 14.2 (to the extent applicable), ) and (iii) *** termination of this Agreement pursuant to Section 6.3 (to the extent applicable, *** but subject to the applicable cure periods set forth therein); provided thatprovided, for clarity, Merck that Pfizer shall not be deemed to be waiving any rights under Section 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 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 8.8.3.
(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 AdaptimmuneRexahn, 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 Adaptimmune Rexahn with respect to any Merck Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) [*** , (ii) *** , and (iii) *** ; ] provided that, for clarity, Adaptimmune Rexahn shall not be deemed to be waiving any rights under Section 8.15. In the event Merck Compound is lost or damaged by Adaptimmune Rexahn after Delivery, Merck shall provide additional Merck Compound (if available for the Study) to AdaptimmuneRexahn; provided that Adaptimmune Rexahn shall [*** *] of such 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 AdaptimmuneRexahn.
(c) Adaptimmune Rexahn shall be responsible for, and Merck shall have no obligation or liability with respect to, any Adaptimmune Rexahn Compound supplied hereunder that is found to have a Non-Conformance. Adaptimmune Rexahn shall replace any Adaptimmune Rexahn Compound as is found to have a Non-Conformance (with respect to Adaptimmune Rexahn 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 Adaptimmune Rexahn Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) [*** *], (ii) [*** (to the extent applicable)*], and (iii) [*** (to the extent applicable, *** ); ] provided that, for clarity, Merck shall not be deemed to be waiving any rights under Section 8.15.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (Rexahn Pharmaceuticals, Inc.)
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 Section 8.8.1Sections 8.7.1 (After Manufacturer'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 8.8.38.8 (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 AdaptimmuneContext, 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 Adaptimmune 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 Menarini Compound as set forth in this Section 8.7.2(b), and (ii) *** , and indemnification under Section 14.2 (iii) *** to the extent applicable); provided thatprovided, for clarity, Adaptimmune that Context shall not be deemed to be waiving any rights under Section 8.15. In the event Merck that Menarini Compound is lost or damaged by Adaptimmune after Delivery, Merck the Parties shall provide additional Merck Compound discuss a replacement supply at reasonable cost (if available for which shall not exceed Menarini’s direct cost of goods of the Study) to Adaptimmune; provided that Adaptimmune shall Menarini Compound, including shipment costs plus [*** *]) and reasonable timelines. Except as set forth in For the foregoing sentenceavoidance of doubt, 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 AdaptimmuneContext. 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) Adaptimmune c. Context shall be responsible for, and Merck Menarini shall have no obligation obligations or liability with respect to, any Adaptimmune Context Compound supplied hereunder that is found to have a Non-Conformance. Adaptimmune Context shall replace any Adaptimmune Context Compound as is found to have a Non-Conformance (with respect to Adaptimmune Context 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 Menarini with respect to any Adaptimmune Context Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) *** replacement of such Context Compound as set forth in this Section 8.7.2(c), and (ii) *** indemnification under Section 14.2 (to the extent applicable), and (iii) *** (to the extent applicable, *** ); provided thatprovided, for clarity, Merck that Menarini shall not be deemed to be waiving any rights under Section 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 Compounds may have a Non-Non- Conformance, despite any testing and quality assurance activities (including any activities conducted by the Parties under Section 8.8.112.11 (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 8.8.312.13 (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 AdaptimmuneGSK, 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 Adaptimmune 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 SpringWorks Compound as set forth in this Section 12.12(b), and (ii) *** , indemnification under Article 22 (to the extent applicable) and (iii) *** ; termination of this Agreement pursuant to Section 24.2 (to the extent applicable, but subject to the applicable cure periods set forth therein), provided that, for clarity, Adaptimmune GSK shall not be deemed to be waiving any of its rights under Section 8.15to recall Compounds in accordance with the Clinical Quality Agreement. In the event Merck that SpringWorks Compound is lost or damaged by Adaptimmune GSK after Delivery, Merck SpringWorks shall use Commercially Reasonable Efforts to provide additional Merck SpringWorks Compound (if available for the Study) to AdaptimmuneGSK; provided that Adaptimmune shall *** . 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 Adaptimmune.GSK shall
(c) Adaptimmune GSK shall be responsible for, and Merck SpringWorks shall have no obligation obligations or liability with respect to, any Adaptimmune Compound supplied hereunder GSK BCMA Product that is found to have a Non-Non- Conformance. Adaptimmune shall replace any Adaptimmune Compound as is found to have a Non-Conformance (with respect to 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 Adaptimmune Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) *** , (ii) *** (to the extent applicable), and (iii) *** (to the extent applicable, *** ); provided that, for clarity, Merck shall not be deemed to be waiving any rights under Section 8.15.
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 Section 8.8.18.5.1), 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 8.8.38.6 (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 AdaptimmuneSponsor, 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 Adaptimmune 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 Lilly Compound as set forth in this Section 8.5.2(b), (ii) *** , indemnification under Section 14.2 (to the extent applicable) and (iii) *** ; provided thattermination of this Agreement pursuant to Section 6.3 (to the extent applicable, for clarity, Adaptimmune shall not be deemed but subject to be waiving any rights under Section 8.15the applicable cure periods set forth therein). In the event Merck that Lilly Compound is lost or damaged by Adaptimmune after Delivery, Merck Lilly shall provide additional Merck Lilly Compound (to Sponsor, if available for the Study) to Adaptimmune; , provided that Adaptimmune Sponsor shall *** . Except as set forth in reimburse Lilly for the foregoing sentenceDirect Manufacturing Costs and Indirect Manufacturing Costs of such replaced Lilly Compound to the extent that the loss or damage is due to the negligence of Sponsor or any of its vendors, Merck subcontractors or Affiliates, and provided further that 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 AdaptimmuneSponsor (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) Adaptimmune Sponsor shall be responsible for, and Merck Lilly shall have no obligation obligations or liability with respect to, any Adaptimmune Sponsor Compound supplied hereunder that is found to have a Non-Conformance. Adaptimmune Sponsor shall replace any Adaptimmune Sponsor Compound as is found to have a Non-Conformance (with respect to Adaptimmune Sponsor 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 Lilly with respect to any Adaptimmune Sponsor Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) *** replacement of such Sponsor Compound as set forth in this Section 8.5.2(c), (ii) *** indemnification under Section 14.2 (to the extent applicable), ) and (iii) *** termination of this Agreement pursuant to Section 6.3 (to the extent applicable, *** but subject to the applicable cure periods set forth therein); provided that, for clarity, Merck shall not be deemed to be waiving any rights under Section 8.15.
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 may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under 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 8.8.3.
(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 AdaptimmuneCompany, 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 Adaptimmune Company with respect to any Merck Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) *** , (ii) *** , and (iii) *** ; provided that, for clarity, Adaptimmune Company shall not be deemed to be waiving any rights under Section 8.15. In the event Merck Compound is lost or damaged by Adaptimmune Company after Delivery, Merck shall provide additional Merck Compound (if available for the Study) to AdaptimmuneCompany; provided that Adaptimmune Company shall *** . 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 AdaptimmuneCompany.
(c) Adaptimmune Company shall be responsible for, and Merck shall have no obligation or liability with respect to, any Adaptimmune Company Compound supplied hereunder that is found to have a Non-Conformance. Adaptimmune Company shall replace any Adaptimmune Company Compound as is found to have a Non-Conformance (with respect to Adaptimmune Company 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 Adaptimmune Company Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) *** , (ii) *** (to the extent applicable), and (iii) *** (to the extent applicable, *** ); provided that, for clarity, Merck shall not be deemed to be waiving any rights under Section 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-Non- Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Section 8.8.18.7.1), 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 8.8.38.7.3.
(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 AdaptimmuneXxxxxxxx, 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 Adaptimmune 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 ImmunoGen Compound as set forth in this Section 8.7.2b), (ii) *** , indemnification under Section 13.2.2 (to the extent applicable) and (iii) *** ; provided thattermination of this Agreement pursuant to Section 6.6 or 6.3 (to the extent applicable, for clarity, Adaptimmune shall not be deemed but subject to be waiving any rights under Section 8.15the applicable cure period set forth therein). In the event Merck ImmunoGen Compound is lost or damaged by Adaptimmune Xxxxxxxx after Delivery, Merck ImmunoGen shall provide additional Merck ImmunoGen Compound (if available for the Study) to AdaptimmuneXxxxxxxx; provided that Adaptimmune Xxxxxxxx shall *** reimburse ImmunoGen for the actual internal and out-of pocket costs reasonably incurred for such replaced ImmunoGen Compound; and provided further that ImmunoGen shall have no obligation to so provide additional ImmunoGen Compound more than once. Except as set forth in the foregoing sentence, Merck 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 AdaptimmuneXxxxxxxx.
(c) Adaptimmune Xxxxxxxx shall be responsible for, and Merck ImmunoGen shall have no obligation obligations or liability with respect to, any Adaptimmune Xxxxxxxx Compound supplied hereunder that is found to have a Non-Non- Conformance. Adaptimmune shall replace any Adaptimmune Compound as is found to have a Non-Conformance (with respect to 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 Adaptimmune Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) *** , (ii) *** (to the extent applicable), and (iii) *** (to the extent applicable, *** ); provided that, for clarity, Merck shall not be deemed to be waiving any rights under Section 8.15.
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 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 8.8.3.
(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 AdaptimmuneIntensity, 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 Adaptimmune [***] with respect to any Merck MSD Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) [*** , (ii) *** , and (iii) *** ; ] provided that, for clarity, Adaptimmune shall not be deemed to be waiving any rights under Section 8.15. [***] In the event Merck MSD Compound is lost or damaged by Adaptimmune Intensity after Delivery, Merck MSD shall provide additional Merck Compound (if available for the Study) to Adaptimmune; [***] provided that Adaptimmune shall [*** . 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 Adaptimmune*] and provided further [***].
(c) Adaptimmune Intensity shall be responsible for, and Merck MSD shall have no obligation or liability with respect to, any Adaptimmune Intensity Compound supplied hereunder that is found to have a Non-Conformance. Adaptimmune Intensity shall replace any Adaptimmune Intensity Compound as is found to have a Non-Conformance (with respect to Adaptimmune Intensity 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 Adaptimmune Intensity Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) be[*** , (ii) *** (to the extent applicable), and (iii) *** (to the extent applicable, *** )]; provided that, for clarity, Merck shall not be deemed to be waiving any rights under Section 8.15[***] .
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-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under 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 8.8.3.
(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 AdaptimmuneCompany, 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 Adaptimmune Company with respect to any Merck Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) *** , (ii) *** , and (iii) *** ; provided that, for clarity, Adaptimmune shall not be deemed to be waiving any rights under Section 8.15. In the event Merck Compound is lost or damaged by Adaptimmune Company after Delivery, Merck shall provide additional Merck Compound (if available for the Study) to AdaptimmuneCompany; provided that Adaptimmune shall *** **. 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 AdaptimmuneCompany.
(c) Adaptimmune Company shall be responsible for, and Merck shall have no obligation or liability with respect to, any Adaptimmune Company Compound supplied hereunder that is found to have a Non-Conformance. Adaptimmune shall Company shall, at its own expense, replace any Adaptimmune Company Compound as is found to have a Non-Conformance (with respect to Adaptimmune Company 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 Adaptimmune Company Compound that is found to have a Non-Non- Conformance at the time of Delivery shall be (i) *** , (ii) *** (to the extent applicable), and (iii) *** (to the extent applicable, *** ); provided that, for clarity, Merck shall not be deemed to be waiving any rights under Section 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 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 8.8.3.
(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 AdaptimmunePDS, 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 Adaptimmune 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 8.8.2(b) (ii) *** indemnification under Section 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); provided that, for clarity, Adaptimmune PDS shall not be deemed to be waiving any rights under Section 8.15. In the event Merck Compound is lost or damaged by Adaptimmune PDS after Delivery, Merck shall provide additional Merck Compound (if available for the Study) to AdaptimmunePDS; provided that Adaptimmune PDS shall reimburse Merck for the Direct Manufacturing Costs and Indirect Manufacturing Costs (as such terms are defined in Section 6.11) of such 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 AdaptimmunePDS.
(c) Adaptimmune PDS shall be responsible for, and Merck shall have no obligation or liability with respect to, any Adaptimmune PDS Compound supplied hereunder that is found to have a Non-Conformance. Adaptimmune PDS shall replace any Adaptimmune PDS Compound as is found to have a Non-Conformance (with respect to Adaptimmune PDS 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 Adaptimmune PDS Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) *** replacement of such PDS Compound as set forth in this Section 8.8.2(b), (ii) *** indemnification under Section 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); provided that, for clarity, Merck shall not be deemed to be waiving any rights under Section 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 Section 8.8.1Sections 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 8.8.38.8 (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 AdaptimmuneVaximm or during the shelf life set forth in Section 8.2 (in either case, a “Non- Conformance Event”), then unless otherwise agreed to by the Parties, 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 Adaptimmune 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 Alliance Compound as is found to have a Non-Conformance (with respect to Alliance Compound that has not yet been administered in the course of performing the Study), (ii) *** , indemnification under Section 14.2 (to the extent applicable) and (iii) *** termination of this Agreement pursuant to Section 6 (to the extent applicable, but subject to the applicable cure periods set forth therein); provided thatprovided, for clarity, Adaptimmune that Vaximm shall not be deemed to be waiving any rights under Section 8.15. In the event Merck that Alliance Compound is lost or damaged by Adaptimmune after Delivery, Merck shall the Alliance may provide additional Merck Alliance 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 Adaptimmunebe 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 Adaptimmune the Manufacturing Costs per vial of Alliance Compound charged by the Alliance pursuant to this Section 8.7.2(b) shall *** not exceed US$95.00. Except as set forth in For the foregoing sentenceavoidance of doubt, 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 Adaptimmune.
(c) Adaptimmune Vaximm. The Alliance shall be responsible for, and Merck shall have no obligation for any costs incurred by Vaximm in connection with the return or liability with respect to, destruction of any Adaptimmune Alliance Compound supplied hereunder that is found to have a Non-ConformanceConformance caused by The Alliance. Adaptimmune shall replace any Adaptimmune Compound as is found to have a Non-Conformance (with respect to 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 Adaptimmune Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) *** , (ii) *** (to the extent applicable), and (iii) *** (to the extent applicable, *** ); provided that, for clarity, Merck shall not be deemed to be waiving any rights under Section 8.15.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 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 8.8.3.
(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 AdaptimmuneCompany, 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 Adaptimmune Company with respect to any Merck Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) [*** ***], (ii) )[*** , ***] and (iii) [*** ***]; provided that, for clarity, Adaptimmune Company shall not be deemed to be waiving any rights under Section 8.15. In the event Merck Compound is lost or damaged by Adaptimmune Company after Delivery, Merck shall provide additional Merck Compound (if available for the Study) to AdaptimmuneCompany; provided that Adaptimmune Company shall [*** ***]. 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 AdaptimmuneCompany.
(c) Adaptimmune Company shall be responsible for, and Merck shall have no obligation or liability with respect to, any Adaptimmune Company Compound supplied hereunder that is found to have a Non-Conformance. Adaptimmune Company shall replace any Adaptimmune Company Compound as is found to have a Non-Conformance (with respect to Adaptimmune Company 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 Adaptimmune Company Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) [*** ***], (ii) [*** (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 that, for clarity, Merck shall not be deemed to be waiving any rights under Section 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 Section 8.8.1Sections 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 8.8.38.8 (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 AdaptimmuneSyndax or during the shelf life set forth in Section 8.2 (in either case, a “Non-Conformance Event”), then unless otherwise agreed to by the Parties, 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 Adaptimmune 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 Alliance Compound as set forth in this Section 8.7.2(b), (ii) *** , indemnification under Section 14.2 (to the extent applicable) and (iii) *** termination of this Agreement pursuant to Section 6.3 (to the extent applicable, but subject to the applicable cure periods set forth therein); provided thatprovided, for clarity, Adaptimmune that Syndax shall not be deemed to be waiving any rights under Section 8.15. In the event Merck that Alliance Compound is lost or damaged by Adaptimmune after Delivery, Merck shall the Alliance may provide additional Merck Alliance Compound (to Syndax, if available for the Study) to Adaptimmune; provided that Adaptimmune . Such replaced Alliance Compound shall ***, so long as the amount replaced *** (the “Replacement Threshold”). Except as set forth in Syndax shall pay the foregoing sentenceAlliance the Manufacturing Costs per vial of any replaced Alliance Compound which the Alliance agrees to supply ***. For the avoidance of doubt, 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 Adaptimmune.
(c) Adaptimmune Syndax. The Alliance shall be responsible for, and Merck shall have no obligation for any costs incurred by Syndax in connection with the return or liability with respect to, destruction of any Adaptimmune Alliance Compound supplied hereunder that is found to have a Non-Conformance. Adaptimmune shall replace any Adaptimmune Compound as is found to have a Non-Conformance (with respect to 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 Adaptimmune Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) *** , (ii) *** (to the extent applicable), and (iii) *** (to the extent applicable, *** ); provided that, for clarity, Merck shall not be deemed to be waiving any rights under Section 8.15.supplied
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (Syndax Pharmaceuticals 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 Section 8.8.1)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 8.8.3.
(bdeemed accepted, except for Idera Compound that is found later to have had latent defect(s) that were not reasonably discoverable within [**] days after receipt of Delivery of such Idera Compound. In the event that any proposed or actual shipment of the Merck Idera Compound (or portion thereof) shall will be agreed to have a Non-Conformance at the time of Delivery to Adaptimmune, then unless or 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 Adaptimmune with respect to any Merck Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) *** , (ii) *** , and (iii) *** ; provided that, for clarity, Adaptimmune shall not be deemed to be waiving any rights under Section 8.15. In the event Merck Compound is lost or damaged by Adaptimmune after Delivery, Merck shall provide additional Merck Compound (if available for the Study) to Adaptimmune; provided that Adaptimmune shall *** . 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 Adaptimmune.
(c) Adaptimmune shall be responsible forAbbVie, and Merck shall have no obligation or liability with respect tothen unless otherwise agreed to by the Parties in writing, any Adaptimmune Compound supplied hereunder that is found Idera will use commercially reasonable efforts to have a Non-Conformance. Adaptimmune shall replace any Adaptimmune such Idera Compound as is found to have a Non-Conformance (with respect as soon as reasonably practical and at no cost to Adaptimmune AbbVie. Any Idera Compound that has not yet been administered or used in relation rejected by written notice to any patient treatment in the course 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 Adaptimmune 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) *** , (ii) *** (to the extent applicable), and (iii) *** (to the extent applicable, *** ); provided that, for clarity, Merck shall not be deemed to be waiving any rights under Section 8.15of such 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 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 8.8.3.
(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 AdaptimmuneCompany, 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 Adaptimmune Company with respect to any Merck Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) [*** ***], (ii) )[*** , ***] and (iii) [*** ***]; provided that, for clarity, Adaptimmune Company shall not be deemed to be waiving any rights under Section 8.15. In the event Merck Compound is lost or damaged by Adaptimmune Company after Delivery, Merck shall provide additional Merck Compound (if available for the Study) to AdaptimmuneCompany; provided that Adaptimmune Company shall [*** ***]. 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 AdaptimmuneCompany.
(c) Adaptimmune Company shall be responsible for, and Merck shall have no obligation or liability with respect to, any Adaptimmune Company Compound supplied hereunder that is found to have a Non-Conformance. Adaptimmune Company shall replace any Adaptimmune Company Compound as is found to have a Non-Conformance (with respect to Adaptimmune Company 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 Adaptimmune Company Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) [*** ***], (ii) [*** (to the extent applicable)***], and (iii) [*** (to the extent applicable, *** )*]; provided that, for clarity, Merck shall not be deemed to be waiving any rights under Section 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 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 8.8.3.
(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 AdaptimmuneCompany, 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 Adaptimmune Company with respect to any Merck MSD Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) [*** , (ii) *** , and (iii) *** ; provided that, for clarity, Adaptimmune shall not be deemed to be waiving any rights under Section 8.15]. In the event Merck MSD Compound is lost or damaged by Adaptimmune Company after Delivery, Merck MSD shall provide additional Merck Compound (if available for the Study) to Adaptimmune; provided that Adaptimmune shall [*** *]; provided, that, [***]. Except as set forth in the foregoing sentence, Merck MSD 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 AdaptimmuneCompany.
(c) Adaptimmune Company shall be responsible for, and Merck MSD shall have no obligation or liability with respect to, any Adaptimmune Company Compound supplied hereunder that is found to have a Non-Conformance. Adaptimmune shall Company shall, at its own expense, replace any Adaptimmune Company Compound as is found to have a Non-Conformance (with respect to Adaptimmune Company 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 MSD with respect to any Adaptimmune Company Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) [*** , (ii) *** (to the extent applicable), and (iii) *** (to the extent applicable, *** ); ] provided that, for clarity, Merck MSD shall not be deemed to be waiving any rights under Section 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 Section 8.8.1Sections 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 8.8.38.8 (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 AdaptimmuneIncyte, 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 Adaptimmune 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 Advaxis Compound as set forth in this Section 8.7.2.2, (ii) *** , indemnification under Section 14.2 (to the extent applicable) and (iii) *** termination of this Agreement pursuant to Section 6.3 (to the extent applicable, but subject to the applicable cure periods set forth therein); provided that, for clarity, Adaptimmune Incyte shall not be deemed to be waiving any rights under Section 8.158.16. In the event Merck Advaxis Compound is lost or damaged by Adaptimmune Incyte after Delivery, Merck Advaxis shall provide additional Merck Advaxis Compound (if available for the Study) to AdaptimmuneIncyte; provided that Adaptimmune Incyte shall *** reimburse Advaxis for the manufacturing and shipping costs of the replaced Advaxis Compound. Except as set forth in the foregoing sentence, 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 AdaptimmuneIncyte.
(c) Adaptimmune 8.7.2.3. Incyte shall be responsible for, and Merck Advaxis shall have no obligation obligations or liability with respect to, any Adaptimmune Incyte Compound supplied hereunder that is found to have a Non-Conformance. Adaptimmune Incyte shall replace any Adaptimmune Incyte Compound as is found to have a Non-Conformance (with respect to Adaptimmune Incyte 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 Advaxis with respect to any Adaptimmune Incyte Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) *** replacement of such Incyte Compound as set forth in this Section 8.7.2.3, (ii) *** indemnification under Section 14.2 (to the extent applicable), ) and (iii) *** termination of this Agreement pursuant to Section 6.3 (to the extent applicable, *** but subject to the applicable cure periods set forth therein); provided that, for clarity, Merck Advaxis shall not be deemed to be waiving any rights under Section 8.158.16.
Appears in 1 contract
Samples: Clinical Study Collaboration 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 Section 8.8.1Sections 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 8.8.38.8 (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 AdaptimmuneAdvaxis, 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 Adaptimmune 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 14.2 (to the extent applicable) and (iii) *** termination of this Agreement pursuant to Section 6.4 (to the extent applicable, but subject to the applicable cure periods set forth therein); provided that, for clarity, Adaptimmune Advaxis shall not be deemed to be waiving any rights under Section 8.158.16. In the event Merck Compound is lost or damaged by Adaptimmune Advaxis after Delivery, Merck shall provide additional Merck Compound (if available for the Study) to AdaptimmuneAdvaxis; provided that Adaptimmune Advaxis shall *** reimburse Merck for the Direct Manufacturing Costs and Indirect Manufacturing Costs (as such terms are defined in Section 6.11) of such 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 AdaptimmuneAdvaxis.
(c) Adaptimmune Advaxis shall be responsible for, and Merck shall have no obligation obligations or liability with respect to, any Adaptimmune Advaxis Compound supplied hereunder that is found to have a Non-Conformance. Adaptimmune Advaxis shall replace any Adaptimmune Advaxis Compound as is found to have a Non-Conformance (with respect to Adaptimmune Advaxis 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 Adaptimmune Advaxis Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) *** replacement of such Advaxis Compound as set forth in this Section 8.7.2(c), (ii) *** indemnification under Section 14.2 (to the extent applicable), ) and (iii) *** termination of this Agreement pursuant to Section 6.4 (to the extent applicable, *** but subject to the applicable cure periods set forth therein); provided that, for clarity, Merck shall not be deemed to be waiving any rights under Section 8.158.16.
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 Compounds may have a Non-Conformance, despite any testing and quality assurance activities (including any activities conducted by the Parties under Section 8.8.112.7 (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 8.8.312.9 (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 AdaptimmuneGSK, 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 Adaptimmune 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 SpringWorks Compound as set forth in this Section 12.8(b), and (ii) *** , indemnification under Article 22 (to the extent applicable) and (iii) *** ; termination of this Agreement pursuant to Section 24.2 (to the extent applicable, but subject to the applicable cure periods set forth therein), provided that, for clarity, Adaptimmune GSK shall not be deemed to be waiving any of its rights under Section 8.15to recall Compounds in accordance with the Clinical Quality Agreement. In the event Merck that SpringWorks Compound is lost or damaged by Adaptimmune GSK after Delivery, Merck SpringWorks shall provide additional Merck SpringWorks Compound (if available for the Sub-Study) to AdaptimmuneGSK; provided that Adaptimmune GSK shall *** . Except as set forth in reimburse SpringWorks for the foregoing sentence, Merck shall have no obligation to provide replacement Merck actual cost of such 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 Adaptimmunewithout markup.
(c) Adaptimmune GSK shall be responsible for, and Merck SpringWorks shall have no obligation obligations or liability with respect to, any Adaptimmune GSK Compound supplied hereunder that is found to have a Non-Conformance. Adaptimmune GSK shall replace any Adaptimmune GSK Compound as is found to have a Non-Conformance (with respect to Adaptimmune Compound that has not yet been administered or used in relation to any patient treatment 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 Adaptimmune GSK Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) *** , replacement of such GSK Compound as set forth in this Section 12.8(c) and (ii) *** indemnification under Article 22 (to the extent applicable), and (iii) *** (to the extent applicable, *** ); provided that, for clarity, Merck shall not be deemed to be waiving any rights under Section 8.15.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (SpringWorks Therapeutics, Inc.)